Latest news with #StewartJ.Tepper
Medscape
05-05-2025
- Health
- Medscape
FDA Okays DHE Nasal Spray for Acute Migraine
The US Food and Drug Administration (FDA) has approved dihydroergotamine (DHE) nasal powder (Atzumi, Satsuma Pharmaceuticals Inc) for the acute treatment of migraine with or without aura in adults Atzumi (previously STS101) is the 'first and only' product utilizing the Simple MucoAdhesive Release Technology (SMART) platform, which combines a proprietary advanced powder and device technology to simplify delivery of DHE, the company said in a news release announcing approval. "DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack,' Stewart J. Tepper, MD, vice president, New England Institute for Neurology and Headache, Stamford, Connecticut, said in the release. 'The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages," Tepper added. The FDA approved Atzumi based on two clinical studies — the phase 1 pharmacokinetics trial and the phase 3 ASCEND open-label, long-term safety trial, which Tepper led. The ASCEND study enrolled adults with a ≥ 1 year history of migraine with or without aura and 4-12 migraine attacks per month and < 15 headache days per month in each of the 3 months prior to screening. The study demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine. Treatment with DHE nasal powder was associated with rapid onset of freedom from pain (37%, 67%, and 86% of treated attacks 2, 4, and 24 hours after dosing, respectively), freedom from most bothersome symptoms (54%, 80%, and 91%), and headache relief (67%, 89%, and 94%). Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine, or migraine with brainstem aura. Complete prescribing information is available online.
Malaysian Reserve
01-05-2025
- Business
- Malaysian Reserve
Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device. Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE. In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability. DURHAM, N.C., April 30, 2025 /PRNewswire/ — Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101. Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain, with symptoms that are often incapacitating. According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women. 'The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology,' said Dr. Ryoichi Nagata, President and CEO of Satsuma. 'We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.' 'DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages', said Dr. Stewart J. Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut. About Atzumi Atzumi is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device. The product is designed to provide patients an easy-to-use and easy-to-carry treatment option. The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine. About Dihydroergotamine (DHE) Since its approval in 1946, DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. IMPORTANT SAFETY INFORMATION WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Atzumi with strong CYP3A4 inhibitors is contraindicated. Indication Atzumi is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. Contraindications Atzumi is not recommended in patients with: Concomitant use of strong CYP3A4 inhibitors Ischemic heart disease or coronary artery vasospasm Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment Hypersensitivity to ergot alkaloids Concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours Concomitant use of peripheral and central vasoconstrictors Warnings and Precautions Atzumi may cause: Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Atzumi under medical supervision (including the use of an electrocardiogram) Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure Medication overuse headache: Detoxification may be necessary Preterm labor: Advise pregnant women of the risk Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Atzumi should not exceed the dosing guidelines or be used for chronic daily administration Local irritation: Local irritation has been reported following administration of Atzumi Most Common Adverse Reactions Most common adverse reactions (incidence >1%) were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. Use in Special Populations Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Atzumi us during pregnancy. Lactation: Patients should not breastfeed during treatment with Atzumi and for 3 days after the last dose. Please see the Atzumi Full Prescribing Information, including Boxed Warning and Medication Guide. The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at You can also call 1-888-273-2480 for additional information. About Satsuma Pharmaceuticals Satsuma Pharmaceuticals Inc., a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. Since its inception in 2016, Satsuma has focused on combining great science, cutting-edge technology and proven drug therapies to create improved therapeutic products that address the significant unmet needs of patients. Satsuma's team has extensive experience successfully developing, manufacturing and commercializing pharmaceutical products within both large and small companies, and we have particular expertise in the area of drug-device combination products delivered via inhalation. For further information, please visit About SNBL Shin Nippon Biomedical Laboratories, Ltd. ('SNBL') (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of 'Committed to the environment, life, and people', and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit Cautionary Note on Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Satsuma's future business, future position and results of operations, including estimates, forecasts, targets and plans for Satsuma. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could' 'anticipates', 'estimates', 'projects' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including uncertainty of commercial success for new and existing products; claims or concerns regarding the safety or efficacy of product candidates; general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; the impact of health crises such as the coronavirus pandemic on Satsuma and its clients and suppliers, including foreign governments in countries in which Satsuma operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Satsuma's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ('Yuka Shoken Houkokusho') and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results. Medical Information This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Inquiries: Satsuma Pharmaceuticals, Inc.E-mail: info@
Business Wire
22-04-2025
- Health
- Business Wire
Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc., ('Click') a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company's prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Re duction in M onthly Mi graine D ays, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product's FDA premarket review. 'This marks a significant milestone for the more than 37 million adults in the US who live with migraine,' said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 'As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.' Click Therapeutics recently presented CT-132 pivotal study results at the American Academy of Neurology Annual Meeting, where co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click shared in a post-conference Medscape article, 'I think this is very exciting as a clinician who takes care of patients because we don't have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don't have access to them.' 'With this landmark, first-in-class FDA authorization in episodic migraine, Click's interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,' said David Benshoof Klein, chief executive officer of Click Therapeutics. 'As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas.' Built on Click's industry-leading AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management. Intended for adjunctive use alongside other treatments for migraine, CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy. CT-132 is thus well-positioned for further development in the future as a software-enhanced drug™ therapy. Click's software-enhanced drug therapies combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients. Click launched its new product offering, Click SE™, in October 2024 to pioneer this new therapeutic category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS). This marketing authorization announcement follows Click's recent Series C funding round news, announced in March 2025. Indication: The CT-132 prescription digital therapeutic is indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. Safety Information: There are no contraindications to using CT-132. CT-132 is not intended to be used as a standalone therapy. CT-132 does not replace or substitute other migraine treatments, including medication for migraine. Patients should continue their current treatment as directed. About the ReMMi-D Pivotal Study and ReMMiD-C Bridging study The indications for use for CT-132 are supported by the results from two double-blind decentralized randomized controlled trials, a pivotal study (ReMMi-D) and a bridging study (ReMMiD-C). The pivotal ReMMi-D study evaluated the effectiveness and safety of CT-132 for the prevention of episodic migraine in patients 18 years and older, compared to a sham digital control and included patients (n=558) on the most commonly prescribed migraine medications. ReMMiD-C was designed identically to ReMMi-D but required that participants (n=110) be taking at least one calcitonin gene-related peptide (CGRP) inhibitor, though participants were also permitted use of non–migraine-specific acute or preventive medications. The study designs mirrored those of contemporary randomized control trials for migraine drugs. However, unlike in drug studies, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated. Both studies demonstrated that CT-132 reduced monthly migraine days (MMDs) compared to a sham digital control in patients already using acute and preventive migraine medications, with no device-related adverse events reported. At the completion of the pivotal ReMMi-D study, CT-132 demonstrated a statistically significant reduction in monthly migraine days (MMDs) after 12 weeks of treatment compared to the sham digital control (n=568, ITT population; treatment difference: –0.9 MMDs; p =0.005). Participants in the treatment arm experienced a mean reduction of –3.04 MMDs by the end of the intervention. Further, migraine related quality of life, assessed by the Migraine-Specific Quality-of-Life Questionnaire (MSQ, revealed a difference between the CT-132 and sham digital control arms from as early as 4 weeks and through weeks 8 and 12. Migraine disability, as measured by the Migraine Disability Assessment (MIDAS) score, improved more in the CT-132 arm than in the sham arm at the end of treatment. Note that the analysis of secondary effectiveness endpoints did not include multiplicity adjustment or formal hypothesis testing. Engagement and adherence were high and sustained over the full 12-week duration of the treatment, with a median of 81 daily lessons out of 84 completed by those receiving the sham digital control and a median of 84 completed by those receiving CT-132. CT-132 was well-tolerated, with no discontinuations due to treatment-emergent adverse events (TEAEs). The ReMMiD-C bridging study provided supportive information, also evaluated versus a sham digital control but without formal hypothesis testing, that demonstrated similar performance of CT-132 in patients taking the new-class of migraine-specific medications, CGRP inhibitors. About Migraine Migraine is a complex and debilitating condition that affects more than 37 million adults and is the second leading cause of disability in the United States. 1,2 It is characterized by episodes of moderate-to-severe headache and is generally associated with nausea and increased sensitivity to light and sound. 3 For those living with migraine, attacks unfold over hours to days and negatively impact key domains of life including employment, educational attainment, and relationships. 4 Despite the availability of preventive migraine medications, there remains a significant unmet need in migraine management. Many patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed. 5 About Prescription Digital Therapeutics Prescription Digital Therapeutics (PDTs) deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated. PDTs can be used independently or in combination with traditional pharmaceutical treatments. About Click Therapeutics Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease. Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click's platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. In 2024, in response to FDA guidance on prescription drug use-related software (PDURS) and building off the capabilities of our platform, we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients. To date, three Click Therapeutics devices have received FDA marketing authorizations. The company's self-developed CT-132, a first-in-class prescription digital therapeutic for preventing episodic migraine, was granted De Novo classification by the FDA. Click Therapeutics, in collaboration with Otsuka, developed Rejoyn™, which became the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms. Additionally, the company expanded its portfolio into cardiometabolic disease with AspyreRx, which received FDA marketing authorization for the treatment of type 2 diabetes. Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit and connect with us on LinkedIn. References
