Latest news with #epinephrine
Yahoo
13-08-2025
- Business
- Yahoo
ARS Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Accelerating Growth for neffy® (epinephrine nasal spray)
$15.7 million in revenue, including $12.8 million in U.S. net product revenue in second quarter of 2025 Growth for in the U.S. driven by increased payor access with additional near-term growth anticipated from national direct-to-consumer (DTC) campaign and pediatric co-promote partnership 93% commercial coverage achieved with streamlined prior authorization process with approval rates at the pharmacy benefit manager (PBM) comparable to overall epinephrine market EURapproved in the United Kingdom and launched in Germany, now representing a global footprint with this first and only needle-free epinephrine treatment Conference call to be held today, August 13, 2025, at 5:30 a.m. PT / 8:30 a.m. ET SAN DIEGO, Aug. 13, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced financial results for the second quarter of 2025, and provided an update on the commercial launch of (epinephrine nasal spray), the first and only FDA-approved and European Commission-approved needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis. 'The second quarter marks a pivotal inflection point for , highlighted by robust growth in prescriptions driven by expanding payor access and strong sales execution,' said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. 'As we move through the peak back-to-school prescribing season and with our most recent DTC investment and co-promote partnership, is rapidly establishing itself as a preferred epinephrine option for patients, caregivers and schools. With continued commercial momentum in the U.S. and an expanded global presence marked by EURapproval in the U.K. and launch in Germany, we are advancing our vision to redefine the standard of care for allergic emergencies while creating lasting value for patients, providers and shareholders alike.' Second Quarter 2025 Financial Results Revenue: Total revenue for the second quarter of 2025 was $15.7 million, which was comprised of $12.8 million in net product revenue from sales in the U.S., $2.6 million in milestone revenue from ALK-Abelló A/S (ALK) related to the launch of EUR® in Germany, and $0.3 million in supply revenue from partners. The cash milestone triggered from ALK to ARS Pharma was $5.0 million, with $2.6 million recognized as revenue and the remaining $2.4 million recorded to the financing liability on the company's balance sheet. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $4.0 million, which was primarily associated with the initiation of the Phase 2b clinical trial in urticaria, the ongoing post-marketing registry study for the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics and other development expenses for . Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2025 were $54.3 million, reflecting the company's substantial investment in the national direct-to-consumer marketing campaign and continued sales and marketing expenses associated with the U.S. commercialization of . The company is committed to investing in the ongoing promotion of to further enhance patient and physician awareness and to continue accelerating market share. Net Loss: Net loss for the second quarter of 2025 was $44.9 million, or $0.46 per share. Cash Runway: As of June 30, 2025, ARS Pharma had cash, cash equivalents, and short-term investments of $240.1 million, with 98,697,658 shares of common stock outstanding. The company reiterates its guidance that its financial position is expected to support its operating plans for at least the next three years. Commercial Launch Progress in the United States Prescription growth:two-pack unit weekly volumes have continued to grow, increasing approximately 180% from the end of first quarter of 2025 to the end of second quarter of 2025. Notably, this volume growth pre-dated the company's rollout of its national DTC campaign. ARS Pharma's DTC campaign was rolled out in two stages, beginning in mid-May with connected TV (streaming) and followed by broadcast/linear TV in late June. The campaign has significantly increased consumer awareness since its late second quarter launch, driving added awareness of from a baseline of approximately 20% pre-campaign to 49% in late July. Consistent with the observed time-to-effect during DTC launch campaigns for other pharmaceutical products, further script momentum is expected in the second half of 2025 and beyond. Commercial coverage goal exceeded: 93% commercial coverage, including 57% without prior authorization, has been secured thus far with access and approval rates across the major PBMs consistent with the overall epinephrine market. Further, prior authorizations that are still required by a portion of payors under Zinc, a Group Purchasing Organization affiliated with CVS Caremark, one of the largest PBMs in the U.S., are being approved at more than an 80% success rate. Notably, the proportion of dispensed prescriptions that is represented by payors under Zinc is currently in line with the overall epinephrine market despite the requirement for prior authorizations by a portion of payors under Zinc. 52% gross-to-net retention for Q2 2025: Payor access has reached a critical milestone, with gross-to-net retention now at projected steady-state levels, where it should remain moving forward even with future coverage decisions by the remaining PBMs. Additional highlights from the U.S. commercial launch include: HCP adoption: Over 9,700 HCPs have prescribed to date, which represents a 73% increase from April 2025, of which about 70% continue to be among the highest decile prescribing HCPs. Allergist real-world experience: Approximately 2,800 allergists have enrolled in the Experience Program, with approximately 20,000 doses across both 2 mg and 1 mg on hand for in-office use during an anaphylaxis event occurring during oral food challenges or allergen immunotherapy. School access expansion: More than 3,200 schools have opted into the inSchools program, each receiving two cartons (four single-use doses) of 2 mg or 1 mg at no cost for emergency use through the School Health Corp. SHConnect platform. U.S. registry study ongoing: The ARS Pharma post-marketing registry-based randomized controlled study of for the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics in the U.S. is ongoing. 'A key factor driving our growth and momentum has been achieving a critical milestone in payor access, which has significantly reduced administrative barriers for providers,' said Eric Karas, Chief Commercial Officer of ARS Pharma. 'As the volume of continues to increase, we anticipate that the economic factors for the remaining PBMs will continue to reduce prior authorization requirements. Additionally, the combination of our sales force execution and DTC advertising further positions us for market share growth. This, along with a more seamless physician prescribing experience and enhanced consumer awareness, creates a strong foundation for continued commercial expansion.' Global Expansion for and EUR EURapproved in United Kingdom (U.K.): In July 2025, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for EUR 2 mg for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 30 kg – another major milestone as the first needle-free treatment in the largest market outside the U.S. for epinephrine auto-injector sales. Under the companies' license agreement, ALK owns the rights to market EUR in the U.K. and expects 2 mg product availability beginning late in the second half of 2025. EURlaunched in Germany: ALK successfully launched EUR® 2 mg in Germany in June 2025, triggering a $5.0 million milestone payment under the two companies' licensing agreement. This represents the first commercial launch outside the U.S., and we believe it is indicative of the global demand for our intranasal epinephrine product. EUR1 mg under review by EMA: EUR® 1 mg for children weighing 15 to < 30 kg is currently undergoing regulatory review by the European Medicines Agency (EMA), with approval anticipated in the first half of 2026. Additional regulatory approvals anticipated: Regulatory approvals for in Canada (with ALK-Abelló), Japan (in partnership with Alfresa), and Australia (in partnership with CSL), are expected by the end of 2025, with commercial rollouts planned in the first half of 2026. Regulatory approval for in China (in partnership with Pediatrix) is expected in the first half of 2026. Clinical Expansion of Intranasal Epinephrine Program Phase 2b trial in urticaria initiated: In June 2025, ARS Pharma initiated a Phase 2b clinical trial (NCT06927999) to evaluate its intranasal epinephrine technology as a treatment for acute flares in patients with chronic spontaneous urticaria. The trial is enrolling patients in the U.S. and Europe, with topline data anticipated in the first half of 2026. This program expansion represents a significant opportunity to extend the utility of the company's intranasal epinephrine technology to a new indication affecting approximately two million people in the U.S. alone. Conference Call and Webcast Information ARS Pharma management will host a conference call and webcast at 5:30 a.m. PT / 8:30 a.m. ET today, August 13, 2025. To access the webcast and slides, please visit the Events & Presentations page in the Investors & Media section of the Company's website. A replay of the webcast will be available for 30 days following the event. Dial-in information for conference participants may be obtained by registering for the event. EUR is the trade name for ® (epinephrine nasal spray) in Europe. About is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater. INDICATION AND IMPORTANT SAFETY INFORMATION FOR (epinephrine nasal spray) INDICATION is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater. IMPORTANT SAFETY INFORMATION contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Always carry two nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of if symptoms continue or come back. Each contains a single dose of epinephrine. is for use in the nose only. Use right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of , a second dose is needed. If needed, administer a second dose using a new in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using . Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. and other medications may affect each other, causing side effects. may affect the way other medicines work, and other medicines may affect how works. may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use . Common side effects of include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using . These are not all of the possible side effects of . Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or Please see the full Prescribing Information and Patient Information for . About Type I Allergic Reactions Including Anaphylaxis Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency. About ARS Pharmaceuticals, Inc. ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing (trade name EUR in the EU), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients 4 years of age and older who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit Forward Looking Statements Statements in this press release that are not purely historical in nature are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: ARS Pharma's guidance that its financial position is expected to support its operating plans for at least the next three years; the expectation for further script momentum in the second half of 2025 and beyond; the projection that gross-to-net retention is now at steady-state levels at approximately 50% and that this will provide greater predictability for revenue modeling; the expectation that PBMs will continue to reduce prior authorization requirements; the belief that ARS Pharma is positioned for market share growth and continued commercial expansion; the belief that the commercial launch in Germany is indicative of global demand for ARS Pharma's intranasal epinephrine product; the anticipated timing for topline data from the urticaria trial and the potential for ARS Pharma's intranasal epinephrine technology to expand into the urticaria indication, and the estimated patient population for this indication; the anticipated timing of regulatory decisions for and the expected timing of commercial launches in Canada, China, Japan and Australia; the anticipated timing of the EMA's regulatory decisions for ; the expected timing of commercial launch in the U.K.; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'believe,' 'can,' 'could,' 'expect,' 'if,' 'may,' 'potential,' 'plan,' 'will,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from ; the ability to maintain regulatory approval forin its currently approved indications; the scope, progress and expansion of developing and commercializing ; the scope, progress and expansion of developing our intranasal epinephrine technology; clinical trial results; the potential for governments and payors to delay, limit or deny coverage for ; the size and growth of the market for and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma's ability to protect its intellectual property position; and the impact of government laws, regulations and policies. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission ('SEC') on May 14, 2025 and in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, to be filed with the SEC today. These documents can also be accessed on ARS Pharma's website at by clicking on the link 'Financials & Filings' under the 'Investors & Media' tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit and follow us on LinkedIn and X. Investor Contact:Justin Chakma, ARS Pharmajustinc@ Media Contact:Christy Curran, Sam Brown ARS Pharmaceuticals, Consolidated Balance Sheets(in thousands, except share and par value data) June 30, 2025 December 31, 2024 (unaudited) Assets Current assets: Cash and cash equivalents $ 51,540 $ 50,817 Short-term investments 188,590 263,205 Accounts receivable, net 25,126 8,175 Inventories 8,738 5,212 Prepaid expenses and other current assets 7,442 6,886 Total current assets 281,436 334,295 Long-term inventories 13,374 5,307 Right-of-use asset 1,564 37 Fixed assets, net 1,075 1,029 Intangible assets, net 12,972 7,371 Other assets 3,051 3,114 Total assets $ 313,472 $ 351,153 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities (including related party amounts of $1,091 and $656, respectively) $ 44,264 $ 22,841 Contract liability, current 746 557 Lease liability, current 589 42 Total current liabilities 45,599 23,440 Financing liability 71,959 69,383 Contract liability, net of current portion 1,103 1,532 Total liabilities 121,151 94,355 Commitments and contingencies Stockholders' equity Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized at June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 — — Common stock, $0.0001 par value per share; 200,000,000 shares authorized at June 30, 2025 and December 31, 2024; 98,697,658 and 97,954,172 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 10 10 Additional paid-in capital 394,485 379,873 Accumulated other comprehensive (loss) gain, net (46 ) 220 Accumulated deficit (202,128 ) (123,305 ) Total stockholders' equity 192,321 256,798 Total liabilities and stockholders' equity $ 313,472 $ 351,153 ARS Pharmaceuticals, Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenue: Product revenue, net $ 12,800 $ — $ 20,563 $ — Revenue under collaboration agreements 2,594 500 2,804 500 Revenue under supply agreements 323 — 323 — Total revenue 15,717 500 23,690 500 Operating expenses: Cost of goods sold (including related party amounts of $866, $0, $1,354, and $0, respectively) 4,984 — 6,078 — Research and development (including related party amounts of $582, $518, $1,245, and $1,245, respectively) 4,035 6,896 6,987 12,130 Selling, general and administrative (including related party amounts of $107, $114, $231, and $208, respectively) 54,312 8,944 95,416 16,902 Total operating expenses 63,331 15,840 108,481 29,032 Loss from operations (47,614 ) (15,340 ) (84,791 ) (28,532 ) Other income, net 2,731 2,824 5,968 5,724 Net loss $ (44,883 ) $ (12,516 ) $ (78,823 ) $ (22,808 ) Change in unrealized gains and losses on available-for-sale securities (118 ) (21 ) (266 ) (194 ) Comprehensive loss $ (45,001 ) $ (12,537 ) $ (79,089 ) $ (23,002 ) Net loss per share, basic and diluted $ (0.46 ) $ (0.13 ) $ (0.80 ) $ (0.24 ) Weighted-average shares outstanding used in computing net loss per share, basic and diluted 98,361,771 96,827,687 98,212,035 96,656,690
Yahoo
01-08-2025
- Health
- Yahoo
Common allergy medication's risks outweigh its usefulness, experts say
Dr. Anna Wolfson says she sees dangerous misuse of the allergy medication diphenhydramine in her clinic every day. 'If someone has an allergic reaction to a food, people will say, 'Don't worry, I have diphenhydramine in my purse,' and I would say, 'Really, epinephrine is the first-line treatment for food allergies,'' said Wolfson, an allergist at Massachusetts General Hospital. Diphenhydramine can be harmful if people take it after having an allergic reaction to food, she said, because the drug – best known by the brand name Benadryl – makes them drowsy and can cause them to miss signs that their symptoms are getting worse. 'It's time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,' she said. 'I've had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.' Wolfson isn't alone in preferring alternatives. In a review published in February, allergy experts from Johns Hopkins University and the University of California, San Diego called for the removal of diphenhydramine from over-the-counter and prescription markets in the United States, saying it's outdated, dangerous and eclipsed by safer alternatives. A first-generation antihistamine approved in 1946, diphenhydramine is widely used for allergies, sleep aid and cold symptoms. It's a common over-the-counter medication in the US, with usage rising in the summer months as people use it to treat itching from bug bites or poison ivy, as well as sneezing and runny nose caused by grass and pollen allergies, according to the American Pharmacists Association. Despite its longstanding presence in American homes, the authors of the new review say it poses disproportionate risks, especially for children and older adults, than newer antihistamines. 'Patients should trial alternatives agents like loratadine, which is Claritin, or cetirizine, which is Zyrtec, or fexofenadine, which is Allegra,' to alleviate allergy symptoms, Dr. James Clark of the Department of Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine, the lead author of the paper, told CNN. The Consumer Healthcare Products Association, which represents the OTC medicine industry, says that common side effects associated with products containing diphenhydramine are disclosed on the label. However, it notes, 'these products are not intended for long-term use.' 'When used as directed, these medicines provide well-established therapeutic benefits for common health ailments like allergies, the common cold, motion sickness, minor skin irritations, and occasional sleeplessness,' the group said in a statement on behalf of Benadryl's maker, Kenvue. 'Like all medicines, responsible use is essential, and consumers should always follow directions and warnings on the Drug Facts labels and consult healthcare providers if they have questions.' Risks of diphenhydramine Antihistamines work by blocking receptors called H1, part of the body's system for responding to allergens, which trigger symptoms like sneezing, itching and a runny nose. But older drugs like diphenhydramine don't just block the allergy-related receptors, they can also affect other parts of the brain. Diphenhydramine often causes sedation, cognitive impairment, and in some cases, dangerous cardiac effects, the authors wrote. In older adults, the drug can stay in the body for up to 18 hours, resulting in lingering sleepiness, disorientation and increasing risk of falling. The review also highlighted a possible link between long-term diphenhydramine use and dementia. In children, the risks can be even more pronounced. The review's authors cite cases of accidental overdose; paradoxical reactions such as agitation, extreme sedation and coma; and even death, particularly with pediatric formulations, because of accidental ingestions. The medication was linked to several child hospitalizations and fatalities during the viral 'Benadryl Challenge' on TikTok. Dr. Manuela Murray, director of general pediatrics and urgent care at the University of Texas Medical Branch, says diphenhydramine 'should not be used lightly.' 'It should always be used under the guidance of a Medical Professional, and it is only indicated to treat allergic reactions and motion sickness,' Murray wrote in an email. The medication is often misused and 'doesn't offer a benefit for treatment of cold symptoms, and it is not a safe sleep aid medication,' she said. In fact, it can have the opposite effects in children, leading to hyperactivity. Dr. Alyssa Kuban, a pediatrician and associate medical director at Texas Children's Pediatrics, also said that she finds diphenhydramine overused for symptoms it does not directly treat and that there are safer alternatives. 'I see some families use diphenhydramine when the child has a cold or upper respiratory infection, thinking it will help with the congestion and help them to sleep better at night,' she said. 'This is not effective for cold symptoms, nor is it very safe.' She recommends over-the-counter cetirizine to treat children with hives, seasonal allergies or an itchy rash. Cetirizine is also longer-lasting and not as sedating as diphenhydramine, she says. Murray agrees that loratadine and cetirizine are safer for children over 6 months, and saline drops and suctioning are better alternatives for infants. 'Time to say a final goodbye' Diphenhydramine appears in over 300 OTC formulations, often blended into combination products for coughs, colds and flu. The authors of the review say that, like products with pseudoephedrine, diphenhydramine should at minimum be moved behind the counter, allowing pharmacists to guide patients toward second-generation alternatives. The American Pharmacists Association says patients should use caution with combination cough and cold products that contain diphenhydramine. Pharmacists may recommend alternative medications for older adults who have a history of being cognitively affected by certain medications, the group says, and it 'encourages patients and parents/caregivers to ask their pharmacist for the most appropriate treatment recommendation for their symptoms' with the least amount of side effects. The review authors also emphasize that there is no strong clinical data that may suggest that diphenhydramine works better than other options. Although it may reduce symptoms like sneezing and itching, it has minimal effect on nasal congestion and doesn't outperform second-generation drugs in randomized trials. Newer options, such as oral cetirizine, offer 24-hour coverage with fewer adverse events. However, in the US, the medication remains a staple. According to the review, more than 1.5 million prescriptions are still written annually, not counting untracked OTC purchases. 'In the past, it has been a useful medication that has helped millions of patients; however, its current therapeutic ratio is matched or exceeded by second-generation antihistamines, especially due to their markedly reduced adverse reactions. It is time to say a final goodbye to diphenhydramine, a public health hazard,' the authors wrote. Solve the daily Crossword
CNN
01-08-2025
- Health
- CNN
Common allergy medication's risks outweigh its usefulness, experts say
Dr. Anna Wolfson says she sees dangerous misuse of the allergy medication diphenhydramine in her clinic every day. 'If someone has an allergic reaction to a food, people will say, 'Don't worry, I have diphenhydramine in my purse,' and I would say, 'Really, epinephrine is the first-line treatment for food allergies,'' said Wolfson, an allergist at Massachusetts General Hospital. Diphenhydramine can be harmful if people take it after having an allergic reaction to food, she said, because the drug – best known by the brand name Benadryl – makes them drowsy and can cause them to miss signs that their symptoms are getting worse. 'It's time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,' she said. 'I've had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.' Wolfson isn't alone in preferring alternatives. In a review published in February, allergy experts from Johns Hopkins University and the University of California, San Diego called for the removal of diphenhydramine from over-the-counter and prescription markets in the United States, saying it's outdated, dangerous and eclipsed by safer alternatives. A first-generation antihistamine approved in 1946, diphenhydramine is widely used for allergies, sleep aid and cold symptoms. It's a common over-the-counter medication in the US, with usage rising in the summer months as people use it to treat itching from bug bites or poison ivy, as well as sneezing and runny nose caused by grass and pollen allergies, according to the American Pharmacists Association. Despite its longstanding presence in American homes, the authors of the new review say it poses disproportionate risks, especially for children and older adults, than newer antihistamines. 'Patients should trial alternatives agents like loratadine, which is Claritin, or cetirizine, which is Zyrtec, or fexofenadine, which is Allegra,' to alleviate allergy symptoms, Dr. James Clark of the Department of Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine, the lead author of the paper, told CNN. The Consumer Healthcare Products Association, which represents the OTC medicine industry, says that common side effects associated with products containing diphenhydramine are disclosed on the label. However, it notes, 'these products are not intended for long-term use.' 'When used as directed, these medicines provide well-established therapeutic benefits for common health ailments like allergies, the common cold, motion sickness, minor skin irritations, and occasional sleeplessness,' the group said in a statement on behalf of Benadryl's maker, Kenvue. 'Like all medicines, responsible use is essential, and consumers should always follow directions and warnings on the Drug Facts labels and consult healthcare providers if they have questions.' Antihistamines work by blocking receptors called H1, part of the body's system for responding to allergens, which trigger symptoms like sneezing, itching and a runny nose. But older drugs like diphenhydramine don't just block the allergy-related receptors, they can also affect other parts of the brain. Diphenhydramine often causes sedation, cognitive impairment, and in some cases, dangerous cardiac effects, the authors wrote. In older adults, the drug can stay in the body for up to 18 hours, resulting in lingering sleepiness, disorientation and increasing risk of falling. The review also highlighted a possible link between long-term diphenhydramine use and dementia. In children, the risks can be even more pronounced. The review's authors cite cases of accidental overdose; paradoxical reactions such as agitation, extreme sedation and coma; and even death, particularly with pediatric formulations, because of accidental ingestions. The medication was linked to several child hospitalizations and fatalities during the viral 'Benadryl Challenge' on TikTok. Dr. Manuela Murray, director of general pediatrics and urgent care at the University of Texas Medical Branch, says diphenhydramine 'should not be used lightly.' 'It should always be used under the guidance of a Medical Professional, and it is only indicated to treat allergic reactions and motion sickness,' Murray wrote in an email. The medication is often misused and 'doesn't offer a benefit for treatment of cold symptoms, and it is not a safe sleep aid medication,' she said. In fact, it can have the opposite effects in children, leading to hyperactivity. Dr. Alyssa Kuban, a pediatrician and associate medical director at Texas Children's Pediatrics, also said that she finds diphenhydramine overused for symptoms it does not directly treat and that there are safer alternatives. 'I see some families use diphenhydramine when the child has a cold or upper respiratory infection, thinking it will help with the congestion and help them to sleep better at night,' she said. 'This is not effective for cold symptoms, nor is it very safe.' She recommends over-the-counter cetirizine to treat children with hives, seasonal allergies or an itchy rash. Cetirizine is also longer-lasting and not as sedating as diphenhydramine, she says. Murray agrees that loratadine and cetirizine are safer for children over 6 months, and saline drops and suctioning are better alternatives for infants. Diphenhydramine appears in over 300 OTC formulations, often blended into combination products for coughs, colds and flu. The authors of the review say that, like products with pseudoephedrine, diphenhydramine should at minimum be moved behind the counter, allowing pharmacists to guide patients toward second-generation alternatives. The American Pharmacists Association says patients should use caution with combination cough and cold products that contain diphenhydramine. Pharmacists may recommend alternative medications for older adults who have a history of being cognitively affected by certain medications, the group says, and it 'encourages patients and parents/caregivers to ask their pharmacist for the most appropriate treatment recommendation for their symptoms' with the least amount of side effects. The review authors also emphasize that there is no strong clinical data that may suggest that diphenhydramine works better than other options. Although it may reduce symptoms like sneezing and itching, it has minimal effect on nasal congestion and doesn't outperform second-generation drugs in randomized trials. Newer options, such as oral cetirizine, offer 24-hour coverage with fewer adverse events. However, in the US, the medication remains a staple. According to the review, more than 1.5 million prescriptions are still written annually, not counting untracked OTC purchases. 'In the past, it has been a useful medication that has helped millions of patients; however, its current therapeutic ratio is matched or exceeded by second-generation antihistamines, especially due to their markedly reduced adverse reactions. It is time to say a final goodbye to diphenhydramine, a public health hazard,' the authors wrote.
Health Line
02-07-2025
- Health
- Health Line
Allergic Reaction First Aid: What to Do
Key takeaways If you or someone you're with is experiencing anaphylaxis, call 911 or your local emergency services immediately. Help them use an epinephrine auto-injector (sometimes called an EpiPen) if they have one. Serious allergic reactions can cause anaphylaxis within minutes of exposure. Without treatment, anaphylaxis can lead to loss of consciousness, respiratory distress, and cardiac arrest. Doctors typically prescribe an epinephrine auto-injector if you have severe allergies. Keep it with you at all times in case of a reaction, and use it at the first indication of symptoms. Your immune system creates antibodies to fight off foreign substances so you don't get sick. But sometimes your system may react to a common substance that is not harmful to most people, such as a food, a medication, or some aspect of your environment. This is called an allergic reaction, and the substances that can cause it are called allergens. When your body comes into contact with an allergen, you might experience mild symptoms like skin irritation, watery eyes, or sneezing. But in some people, allergies can lead to anaphylaxis, which is a life threatening condition. Anaphylaxis results in shock, a sudden drop in blood pressure, and difficulty breathing. It can even cause your breathing to stop and cause your heart to stop beating. Immediately call 911 or your local emergency services if you or someone you're with is experiencing anaphylaxis. What are the symptoms of an allergic reaction? Your body's reaction to an allergen depends on what you're allergic to. Many parts of your body might react, such as your: airways nose skin mouth digestive system Common symptoms The following table shows which symptoms commonly occur with each type of allergy: Symptom Environmental allergy Food allergy Insect sting allergy Drug allergy sneezing X X runny or stuffy nose X skin irritation (itchiness, redness/discoloration, peeling) X X X X hives X X X X rash X X X X nausea or vomiting X diarrhea X trouble breathing, shortness of breath, or wheezing X X X X watery and bloodshot eyes X swelling of your face or the contact area X X X X rapid pulse X X X dizziness X X Anaphylaxis or severe reactions The most serious allergic reactions can cause anaphylaxis within minutes of allergen exposure. Without treatment, anaphylaxis can lead to loss of consciousness, respiratory distress, and cardiac arrest. Symptoms of anaphylaxis include: skin reactions, such as hives, itching, or pale skin wheezing or trouble breathing lightheadedness, dizziness, or fainting facial swelling nausea a weak, fast pulse vomiting diarrhea Get emergency help if you or someone you're with is experiencing anaphylaxis, even if the symptoms start to subside. Symptoms can sometimes return in a second phase of the reaction. What to do when someone is experiencing anaphylaxis If you're with someone who is experiencing anaphylaxis, you should: Call 911 immediately. Find out whether the person has an epinephrine auto-injector (often known by the brand name 'EpiPen') and help them inject the medication if they cannot do it. Try to keep them calm. Help them lie on their back. Raise their feet about 12 inches and cover them with a blanket. Turn them onto their side if they're vomiting or bleeding. Make sure their clothing is loose so they can breathe. The sooner the person gets their epinephrine, the better. Do not give them oral medications or anything to drink. If you have allergies that may lead to an anaphylactic reaction, your doctor can prescribe emergency epinephrine. Each auto-injector contains a single dose of medication that you can inject into your thigh. It's important that you carry an auto-injector with you at all times if you have a history of severe allergies or if your doctor has advised you to do so. You should also teach your family and close friends how to inject the epinephrine in case of an emergency. CPR for anaphylaxis If someone has had an anaphylactic reaction and is not breathing, coughing, or moving, you may need to perform CPR. You can do this even if you don't have formal CPR training. CPR involves doing chest presses, about 100 per minute, until help arrives. If you're interested in learning CPR, you can contact the American Heart Association, the American Red Cross, or a local first aid organization for training. Treatments for allergic reactions Over-the-counter (OTC) antihistamines and decongestants might relieve minor symptoms of an allergic reaction. But you should talk with your doctor before taking any OTC medication to treat allergy symptoms. Antihistamines prevent symptoms such as hives by blocking histamine receptors so your body doesn't react to allergens. Decongestants help clear your nose and are especially effective for seasonal allergies — but do not take them for more than 3 days, as doing so may cause allergic reaction symptoms to return or worsen. These medications are available as tablets, eye drops, and nasal sprays. Many OTC drugs cause drowsiness, so do not take them before driving or doing work that requires a lot of concentration. To help reduce swelling, itching, and skin redness or other discoloration, you can apply ice and topical creams that contain corticosteroids. If OTC medications don't work to reduce your mild allergy symptoms, make an appointment with your doctor. And call your doctor right away if you have an allergic reaction to a medication. Treatments for food allergies The best remedy for a food allergy is usually to prevent a reaction by avoiding foods that trigger your allergy. If you accidentally eat a food you're allergic to or otherwise come into contact with it, OTC drugs can help reduce the reaction. But these drugs can only help relieve hives or itching. Oral cromolyn can help treat your other symptoms. It's available only by prescription, so talk with your doctor. If you have severe food allergies, carry epinephrine with you to treat any reaction you might have. Treatments for plant or bite allergies The treatment for a plant or bite allergy varies depending on the type of allergen. Poisonous plants According to the Journal of the American Medical Association, up to 75% of adults in the United States will have an allergic reaction when they touch poison ivy, poison oak, or poison sumac. A sticky substance on these plants, which is called urushiol, binds to your skin upon contact. Symptoms can range from mild redness and itching to severe blisters and swelling. The first time you have contact with one of these plants, a rash might take up to 3 weeks to appear. But if it's not your first exposure, the rash may develop sooner, within 1 to 2 days. In either case, the rash usually lasts 1 to 3 weeks. If you've touched poisonous plants, take the following steps: Avoid touching other areas of your body, especially your face. Clean the affected area with soap and water for at least 10 minutes. Take a cool bath. Apply calamine lotion or another anti-itching lotion three or four times per day to relieve itching. Soothe inflamed areas with oatmeal products or 1% hydrocortisone cream. Wash all clothing and shoes in hot water. These steps focus on removing the urushiol from your skin. Severe reactions in children may require a doctor's visit, and a doctor may prescribe oral steroids or stronger creams to ease symptoms. Contact your doctor if you have a high fever and any of the following symptoms: worsening itching a rash that spreads to sensitive areas, such as your eyes or mouth a rash that does not improve a rash that is tender or has pus and yellow scabs Despite some claims, there's no scientific evidence to suggest that scratching an open wound leads to poison in your bloodstream. The leftover oil (urushiol) touches only the immediate area. You can avoid spreading the oil by immediately washing the affected area with soap and water. Insect stings Most people will have some reaction to an insect bite, but the most serious reaction is an allergic one. According to the American College of Allergy, Asthma, and Immunology, 1.6% to 5.1% of people in the United States may have had a life threatening allergic reaction to an insect sting at some point. Most common insect stings are from: bees wasps yellow jackets hornets fire ants You can treat insect stings with these first aid methods: Remove the stinger with a straight-edged object, such as a credit card, using a brushing motion. Avoid pulling or squeezing the stinger or using tweezers to remove it, as doing so may release more venom into your body. Wash the area with soap and water, and then apply an antiseptic. Apply hydrocortisone cream or calamine lotion. Cover the area with a bandage. If there's swelling, apply a cold compress to the area. Take an antihistamine to reduce itching, swelling, and hives. Take an OTC pain reliever if needed. If you're pregnant, get the OK from your doctor before taking any OTC medications. Children should not take aspirin because of the risk of a rare but fatal condition called Reye syndrome. Jellyfish stings The American Red Cross recommends taking the following steps if a jellyfish stings you or someone else: Remove any tentacles from the skin. You can rinse them off with seawater or use an object to scrape them off. You can also use your hand, but be sure to cover it with a glove, towel, or plastic bag first. Submerge the affected area of skin in hot water for 20 minutes, or apply another heat source such as a chemical heat pack. Apply lidocaine gel if you have it. (If you don't have a heat source to use in step 2, you can apply this gel right after step 1.) Do not rub the skin or cover it with an elastic bandage. Monitor the person's condition for changes or symptoms of shock. While you might have heard that urinating on a jellyfish sting can reduce the pain, older research has not found it to be helpful. In fact, it might increase the pain. Treatment for drug allergies If you experience a serious drug reaction, antihistamines, corticosteroids, or epinephrine may be necessary to treat it. For most types of drug allergies, your doctor should be able to prescribe an alternative medication to help you avoid a reaction. Otherwise, your doctor might recommend a desensitization procedure, which involves taking small doses of the medication until your body can manage the dosage you need. How to prevent allergic reactions Once you've had an allergic reaction, it's important to identify the trigger and avoid future contact with that allergen. If you have ingredient-specific allergies, check the ingredients on foods or other products before purchase. Applying lotion before going hiking or camping may help prevent poison ivy from spreading or absorbing into your skin. The more you can avoid contact with allergens, the less likely you are to have an allergic reaction. Make sure your family, friends, and co-workers know about your allergies. Tell them where you keep your epinephrine auto-injector and show them how to use it. Teaching others how to treat an allergic reaction can help save a life. Takeaway Allergies to substances such as foods, insect stings, and medications can range from mild to serious. While some allergic reactions may cause only mild irritation, a severe reaction can lead to a life threatening condition called anaphylaxis. Symptoms of anaphylaxis include itching, hives, nausea, and trouble breathing. If you or someone you're with develops symptoms of anaphylaxis, call 911. If you have severe allergies, your doctor will prescribe an epinephrine auto-injector. Carry it with you at all times in case of a reaction, and use it at the first sign of symptoms. For mild allergic reactions, first aid procedures and OTC medications can help reduce pain and irritation.
Yahoo
25-06-2025
- Business
- Yahoo
Bryn Pharma Announces First Participant Dosed in PK/PD Trial with Upgraded Nasal Spray Device, Including First-of-Its-Kind, Two-Doses-in-One Nasal Spray Profile
New clinical trial data with Bryn Pharma's second-generation epinephrine nasal spray expected in Q3 2025 The trial employs an upgraded two-spray nasal spray device providing additional reliability and user experience enhancements Trial includes evaluation of pharmacokinetics ('PK') and pharmacodynamics ('PD') for an innovative two-doses-in-one device ('dual-dose') product profile LEBANON, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Bryn Pharma, Inc., ('Bryn') a privately held pharmaceutical company dedicated to finding novel and convenient ways for patients and caregivers to treat anaphylaxis, today announced that it has dosed the first participant in a clinical trial of its second-generation, needle-free nasal epinephrine spray. A key goal of the study is to evaluate an upgraded version of the two-spray nasal spray device, which incorporates several enhancements over previous versions. As part of the trial, Bryn will also evaluate an innovative two-doses-in-one device ("dual-dose") product profile in which each spray from the device provides a full therapeutic dose, allowing for two complete doses from a single device. Current treatment options require access to two devices at all times due to the significant risk that one dose may not fully resolve symptoms. Bryn's dual-dose profile could address a critical patient need by providing backup dosing within a single device. Data readout from the trial is expected in Q3 2025. "Initiation of this trial marks a milestone for Bryn as we advance our epinephrine nasal spray program with significant enhancements to our nasal spray device, including further reliability enhancements, easier handling, improved comfort and fit, as well as an integrated dose indicator for clear user feedback,' said Joshua Ziel, Chief Executive Officer of Bryn Pharma. 'This trial also provides the exciting opportunity to evaluate our innovative dual-dose profile, which has the potential to revolutionize anaphylaxis care by delivering two complete therapeutic doses in a single, lip-balm sized nasal spray.' Trial Design and Objectives Cohort 1 will evaluate the dual-dose profile. Participants will receive a single-spray dose from the nasal spray device for PK, PD, and safety and tolerability comparisons to injectable epinephrine standards of care. Cohort 2 will evaluate a double-spray dose from the nasal spray device vs injectable epinephrine for PK, PD, and safety and tolerability comparisons. The trial utilizes an upgraded version of the two-spray nasal spray device with enhanced features, including wider finger flanges for easier handling, a tapered nozzle to improve comfort and fit, an integrated dose indicator to provide users with clear feedback, as well as enhanced reliability for emergency-use applications. Results from the trial will add to substantial clinical evidence for Bryn's epinephrine nasal spray program, including completion of four pivotal clinical trials with the nasal spray platform and proprietary formulation. Bryn's innovative approach to anaphylaxis treatment has been recognized by the U.S. Food and Drug Administration (FDA) with Fast Track designation, which is granted to facilitate the development and expedite the review of drugs that address unmet medical needs in serious conditions. This designation underscores the significant potential of Bryn's needle-free epinephrine delivery system to transform emergency anaphylaxis care for patients who face barriers with current injectable treatments. About the Anaphylaxis Treatment Landscape Anaphylaxis is a severe, life-threatening allergic reaction that requires immediate epinephrine treatment to prevent potentially catastrophic outcomes. The incidence of severe allergic reactions and anaphylaxis risk continues to rise dramatically across both children and adults yet the gold-standard treatment has remained largely unchanged since epinephrine autoinjectors were introduced in 1987. More than 50% of patients prescribed autoinjectors do not carry or use them as recommended due to needle phobia, accessibility issues, and portability challenges. The treatment landscape is further complicated by the fact that currently approved epinephrine products for anaphylaxis require immediate access to two full doses, forcing patients to carry 2 devices at all times. These challenges have created significant unmet need for truly portable, needle-free alternatives that help patients leave today's injectable epinephrine standards of care behind. About Bryn Pharma's Epinephrine Nasal Spray Program Bryn Pharma's epinephrine nasal spray program is designed to deliver patients at risk for anaphylaxis with an innovative, second-generation needle-free treatment option that addresses pent-up demand for portable, convenient and accessible epinephrine treatment. Comprised of Bryn's proprietary epinephrine formulation combined with a unique two-spray nasal delivery system, each and every Bryn nasal spray device is designed to be able to achieve higher therapeutic epinephrine levels than today's gold-standard, the 0.3 mg epinephrine autoinjector. Built on a proven active ingredient and device platform, the program benefits from the streamlined 505(b)(2) regulatory pathway in the United States and Bryn Pharma's exclusive device license for epinephrine applications across the United States, Canada, and other major pharmaceutical markets. About Bryn Pharma Bryn Pharma, Inc. ('Bryn'), established in 2017, is a privately held pharmaceutical company founded by patients, for patients. Bryn is focused on positively disrupting the existing market for epinephrine treatment by delivering patients at risk for anaphylaxis with accessible, needle-free, easy-to-use alternatives that better meet patient needs. For more information visit Investor Contact: LifeSci AdvisorsJeremy FefferJFeffer@
