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Key Takeaways:
· The U.S. (FDA) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I allergic reactions.
· The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years.
· It is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announces that the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.).
The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.
“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Florida. “FDA approval of neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.”
Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to life-threatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.
This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed. We thank the FDA staff for their partnership and support in the development of neffy, and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of neffy as an important, life-saving treatment.”
The approval of neffy is based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous pilot and supportive studies. neffy met all defined clinical endpoints and its pharmacokinetic (PK) and pharmacodynamic (PD) data were within the range of approved epinephrine injection products. These data included single- and twice-dosed studies in healthy adults, with self-administration and caregiver administration in Type I allergy patients, in pediatric patients ≥30 kg (66 lbs.) as well as in those with allergic rhinitis (congestion and runny nose). Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain, and no serious adverse events were reported in any clinical study.
Also:
· neffy is expected to be available in the United States within eight weeks of FDA approval for patients who weigh 30 kg or greater (66 lbs.).
· In the interim, patients can visit www.neffy.com to register for product updates, including when telemedicine services will be available.
· ARS Pharma plans to file a supplemental NDA application with the FDA for neffy for children who weigh 15 to <30 kg by the end of the third quarter of 2024.
· In the European Union (EU), neffy received a positive opinion and recommendation for approval from the Committee for Medicinal Products for Human Use, with commercial launch in the EU expected in Q4 2024 following the expected grant of market authorization by the European Commission (EC).
· The shelf life of neffy is 30 months and allows for temperature exposure up to 122°F (50°C), making it a potentially effective treatment if left in a car or outside for a length of time.
