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Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder
Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder

Yahoo

time03-06-2025

  • Business
  • Yahoo

Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder

TEL AVIV, Israel, June 3, 2025 /PRNewswire/ -- Nasus Pharma Ltd. ("Nasus Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based intranasal ("PBI") products addressing acute, community based, medical emergencies, today announced the publication of its phase 2 NS002 clinical study performed at the Clinical Research Unit of Hadassah Medical Center in The Journal of Allergy and Clinical Immunology (Global). NS002 is an Epinephrine powder nasal spray for the treatment of type 1 severe allergies and anaphylaxis. The published article (J Allergy Clin Immunol Global 2025;4:100487) explored the comparative bioequivalence of different dosages of intranasal powder Epinephrine (3.6 and 4 mg) compared to the current standard of care, 0.3 mg EpiPen (Epinephrine intramuscular ("IM") autoinjector). This was an open-label, single-dose, 3-treatment, crossover, randomized study that included 12 healthy volunteers. The study results demonstrated that FMXIN002 (NS002) 4.0 mg had faster and higher absorption by all participants, compared to the IM autoinjector: 91% of subjects achieved the hemodynamic clinical threshold of 100 pg/mL plasma Epinephrine at 6 minutes after administration of FMXIN002(NS002) 4.0 mg compared to 55% of subjects receiving the IM autoinjector. The absorption area under the curve for the first 4 minutes was significantly higher for NS002 4.0 mg (geometric mean: 7.49 h/pg/mL vs 2.06 h/pg/mL, respectively; P= 0.0377). The pharmacodynamic response and safety were comparable among all treatments. No serious adverse events occurred, all events were mild and self-resolved. FMXIN002(NS002) was highly stable at all tested conditions including 5 years at room temperature. Prof. Yuval Tal, Head of Allergy and Clinical Immunology Clinic at Hadassah Medical Center commented: "This study demonstrates that FMXIN002 (NS002) intranasal Epinephrine powder could enable faster and higher absorption of Epinephrine into the plasma during the short therapeutic window required for the treatment of anaphylaxis. I have followed the development of NS002 since its first in-human study and am excited about its potential as a simple, convenient, needle free alternative to IM Epinephrine. Intranasal Epinephrine dry powder represents a transformative advancement in anaphylaxis treatment. Unlike traditional autoinjectors - which are unavailable in many countries, require frequent replacement and often deter use due to needle phobia - this needle-free, compact, and user-friendly formulation could potentially offer in the future an alternative with a shelf life exceeding five years. Its design could facilitate easy and rapid administration, and its portability could allow individuals to carry multiple doses effortlessly. By addressing the limitations of current treatments, this innovation could have the potential to significantly improve accessibility and adherence, ultimately saving lives in emergency situations." About FMXIN002 (NS002) FMXIN002, also known as NS002, is a powder formulation of Epinephrine nasal spray developed by Nasus Pharma based on its unique intranasal powder proprietary technology. The Company believes that FMXIN002 (NS002) may enable people to deliver Epinephrine in emergency situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available Epinephrine autoinjectors. FMXIN002 uses Aptar Pharma's Unidose nasal powder unit dose spray device – an intuitive and easy-to-use device with 360° functionality and precise one-dose nasal drug delivery. Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur within a few minutes, and unless treated promptly, could be fatal. There are approximately 40 million patients with type 1 allergies in the United States alone, of which approximately 20 million patients who experience severe type 1 allergic reactions that may lead to anaphylaxis. About Nasus Pharma Ltd. Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal powder products addressing acute emergency situations in the community such as anaphylactic shock and opioid overdose. Intranasal administration is most suitable for those situations in which rapid treatment is required and could offer multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety. Nasus Pharma's portfolio comprises a number of programs in different stages of development. Forward Looking Statements This press release contains express or implied forward-looking statements. For example, the Company is using forward-looking statements when it discusses FMXIN002 (NS002) its development and potential benefits. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Contact: Info@ Nasus Pharma Ltd. Israelhttps:// Logo - View original content: SOURCE Nasus Pharma

Peoria Civic Center receives donation of Epinephrine injectors
Peoria Civic Center receives donation of Epinephrine injectors

Yahoo

time01-05-2025

  • Health
  • Yahoo

Peoria Civic Center receives donation of Epinephrine injectors

PEORIA, Ill. (WMBD) — The Peoria Civic Center received a donation of Epinephrine injectors on Wednesday. The donation came from the Peoria Chapter of Red Sneakers for Food Allergy Awareness and was presented at 3 p.m. in the civic center's great hall, Peoria Civic Center Senior Marketing Manager Kelsy Martin said. The injectors were provided with food allergy training and certification for the civic center medical staff. Lindsey Spangler of Red Sneakers, Peoria said 33 million Americans have some kind of severe food allergies. 'Epinephrine is the only life-saving medication to help reverse a severe food allergic reaction,' Spangler said. 'Due to epinephrine costs and or lack of education, many people do not carry epinephrine for themselves or their child. When it comes to anaphylaxis, time matters.' General Manager of Peoria Civic Center Rik Edgar said he was thankful for the donation. 'Peoria Civic Center is proud to be among the first entertainment venues in the country to be prepared with undesignated epinephrine (stock epi),' Edgar said. 'We thank Red Sneakers Peoria for their generous donation and the positive impact they are having in our community.' Red Sneakers Peoria raises funds for the EPIPENS through their annual 5k run/walk and fall festival in October. More information about Red Sneakers for Food Allergy Awareness is available here. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Epinephrine Autoinjector Market to Grow by USD 2.44 Billion (2024-2028), Rising Allergy Prevalence Boosts Growth, with AI Powering Market Evolution
Epinephrine Autoinjector Market to Grow by USD 2.44 Billion (2024-2028), Rising Allergy Prevalence Boosts Growth, with AI Powering Market Evolution

Yahoo

time31-01-2025

  • Business
  • Yahoo

Epinephrine Autoinjector Market to Grow by USD 2.44 Billion (2024-2028), Rising Allergy Prevalence Boosts Growth, with AI Powering Market Evolution

NEW YORK, Jan. 31, 2025 /PRNewswire/ -- Report on how AI is driving market transformation - The global epinephrine autoinjector market size is estimated to grow by USD 2.44 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of over 10.59% during the forecast period. Increasing prevalence of allergies is driving market growth, with a trend towards frequent product launches due to government pressure on vendors. However, product recalls and regulatory issues poses a challenge. Key market players include Adamis Pharmaceuticals Corp., ALK Abello AS, Amneal Pharmaceuticals Inc., Bausch Health Companies Inc., BIOPROJET, Crossject, Halozyme Therapeutics Inc., kaleo Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Viatris Inc.. Key insights into market evolution with AI-powered analysis. Explore trends, segmentation, and growth drivers- View Free Sample PDF Epinephrine Autoinjector Market Scope Report Coverage Details Base year 2023 Historic period 2018 - 2022 Forecast period 2024-2028 Growth momentum & CAGR Accelerate at a CAGR of 10.59% Market growth 2024-2028 USD 2.44 billion Market structure Concentrated YoY growth 2022-2023 (%) 8.78 Regional analysis North America, Europe, Asia, and Rest of World (ROW) Performing market contribution North America at 46% Key countries US, Germany, UK, China, and Japan Key companies profiled Adamis Pharmaceuticals Corp., ALK Abello AS, Amneal Pharmaceuticals Inc., Bausch Health Companies Inc., BIOPROJET, Crossject, Halozyme Therapeutics Inc., kaleo Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Viatris Inc. Market Driver The Epinephrine Autoinjector market is witnessing significant trends due to the rising acceptance and increased awareness of these life-saving devices. These handheld devices, also known as epinephrine pens or Epis, are used for self administration during acute anaphylactic reactions caused by allergic diseases such as insect bites or stings. Epinephrine, also known as adrenaline, is a vital medication that counteracts the effects of severe allergic responses by constricting blood vessels and increasing blood flow. Healthcare professionals recommend epinephrine autoinjectors for prompt intervention during anaphylactic shock. The market is seeing in demand for pre-filled, specific dose autoinjectors, including needle-free injectors and innovative technologies. Consumer preference for convenient and user-friendly devices is driving the market. Companies like Amphastar Pharmaceuticals are introducing generic versions to cater to the increasing demand and decreasing the burden of allergies. However, recurring product recalls and the rate of diagnosis remain challenges. Digital health platforms and autoinjector training are essential to improve patient awareness and ensure proper usage. The US epinephrine autoinjector market is expected to experience several new product launches in the upcoming years due to increased pressure from the US government for FDA approval of generic alternatives to leading brands like Viatriss EpiPen. This follows the price increase of Viatriss EpiPen, prompting US Governor Margaret Wood Hassan to advocate for more options. Companies such as Bausch Health and ALK Abello, with significant European market presence, may enter the US market in response to this initiative. For instance, Teva Pharmaceutical Industries launched their AJOVY in the prefilled YpsoMate 2 in March 2020. Request Sample of our comprehensive report now to stay ahead in the AI-driven market evolution! Market Challenges The Epinephrine Autoinjector market faces challenges in ensuring accurate dosage for various age groups during acute anaphylactic reactions caused by allergic diseases, such as insect bites or stings. Healthcare professionals emphasize the importance of prompt intervention with epinephrine, also known as Adrenaline, as a life-saving medication for severe allergic reactions. Epinephrine autoinjectors, like epipens and epinephrine pens, are handheld devices that provide convenience and consumer preference for self-administration. However, challenges persist in the form of recurring product recalls, rising acceptance of generic goods from companies like Amphastar Pharmaceuticals, and increasing awareness of innovative technologies like needle-free injectors. Digital health platforms and autoinjector training aim to improve patient awareness and counteract the burden of allergies, while pre-filled, specific dose epinephrine autoinjectors continue to be essential for bronchodilator effects that improve blood flow and counteract anaphylactic shock. The epinephrine autoinjector market has encountered challenges due to product recalls and regulatory hurdles. FDA approval for these devices has been a lengthy process, enabling Viatris to dominate the US market. Following Sanofi's exit, Viatris held a monopoly, partly due to the FDA's limited approval of competitors' products and partly because Impax Laboratories (now Amneal Pharmaceuticals) lacked an automated manufacturing facility for generic Adrenaclick supply. Given the critical importance of accurate epinephrine dose delivery during anaphylactic shock emergencies, product recalls are a necessary response. Discover how AI is revolutionizing market trends- Get your access now! Segment Overview This epinephrine autoinjector market report extensively covers market segmentation by Type 1.1 0.30gm 1.2 0.15gm 1.3 0.50gm End-user 2.1 Hospitals 2.2 clinics 2.3 Homecare Geography 3.1 North America 3.2 Europe 3.3 Asia 3.4 Rest of World (ROW) Age Group 1.1 0.30gm- The global epinephrine autoinjector market for the 0.30gm dosage segment is projected to experience significant growth due to increasing sales of generic options. Amneal Pharmaceuticals' Adrenaclick and Viatris' upcoming generic EpiPen have gained traction following price hikes by key players. In Europe, market share for Viatris may decline due to the availability of multiple brands. The gradual price increases by Viatris and the exit of competitors have encouraged research and development of alternatives, ensuring market expansion for epinephrine autoinjectors in the forecast period. Download a Sample of our comprehensive report today to discover how AI-driven innovations are reshaping competitive dynamics Research Analysis Epinephrine autoinjectors are handheld devices used to deliver a pre-measured dose of epinephrine during acute anaphylactic reactions. These injectors are essential for individuals with allergic diseases, particularly those prone to severe allergic responses from insect bites or stings. The dosage in epinephrine autoinjectors varies, but they are typically designed for use by individuals or their caregivers, making them accessible during emergencies. Epinephrine, also known as adrenaline, is a vital medication for reversing anaphylaxis, a life-threatening allergic response. Innovative technologies have led to the development of needle-free injectors and generic epinephrine autoinjectors, increasing acceptance and accessibility in the healthcare industry. Epinephrine autoinjectors come in different brands like epinephrine pens and EpiPens, catering to various age groups. Market Research Overview Epinephrine autoinjectors, also known as epinephrine pens or EpiPens, are handheld devices that deliver a specific dose of epinephrine, a life-saving medication for individuals experiencing acute anaphylactic reactions due to allergic diseases such as insect stings or food allergies. These devices are essential for prompt intervention during severe allergic responses, counteracting the effects of narrowing blood vessels and decreased blood flow caused by anaphylaxis. The market for epinephrine autoinjectors is witnessing increasing acceptance and awareness, driven by the convenience and consumer preference for self-administration devices. The rising burden of allergies and the need for prompt intervention have led to the development of innovative technologies, including needle-free injectors and digital health platforms for autoinjector training. The market includes pre-filled epinephrine autoinjectors in various dosages for different age groups, with both branded and generic versions available. However, recurring product recalls and the rate of diagnosis remain challenges for the industry. Epinephrine, also known as adrenaline, is a vital medication used to treat anaphylactic shock, a potentially fatal allergic reaction. Table of Contents: 1 Executive Summary2 Market Landscape3 Market Sizing4 Historic Market Size5 Five Forces Analysis6 Market Segmentation Type End-user Geography Age Group 7 Customer Landscape8 Geographic Landscape9 Drivers, Challenges, and Trends10 Company Landscape11 Company Analysis12 Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio ResearchJesse MaidaMedia & Marketing ExecutiveUS: +1 844 364 1100UK: +44 203 893 3200Email: media@ View original content to download multimedia: SOURCE Technavio

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