FDA Approves Needle-Free Epinephrine Nasal Spray neffy® for Type I Allergic Reactions

ARS Pharmaceuticals, Inc., a biopharmaceutical firm specializing in treatments for severe allergic reactions, has announced the FDA's approval of neffy® (epinephrine nasal spray) 2 mg. This marks the first novel epinephrine delivery method in over 35 years, providing a needle-free option for adults and children weighing 30 kg or more who suffer from Type I allergic reactions, including anaphylaxis.

Traditionally, severe allergic reactions were managed using needle-based epinephrine injections, which many patients found painful and anxiety-inducing. This often led to treatment delays, increasing the risk of severe reactions that required emergency medical attention. Dr. Thomas B. Casale from the University of South Florida notes that neffy offers a long-awaited, easy-to-carry solution that can streamline administration and potentially lead to better clinical outcomes and improved quality of life for patients and caregivers.

Type I allergic reactions, triggered by elements such as food, medication, and insect stings, can lead to anaphylaxis and account for approximately 500,000 emergency room visits annually. Alarmingly, around 60% of these patients do not receive epinephrine before reaching the ER. With the introduction of neffy, ARS Pharmaceuticals aims to address this gap by providing a user-friendly, needle-free alternative. Richard Lowenthal, CEO of ARS Pharmaceuticals, emphasized that the effectiveness of epinephrine hinges on its timely and proper administration. The new nasal spray format is designed to be easily portable and quick to use, thereby reducing barriers to prompt treatment.

The FDA's approval of neffy is underpinned by data from five primary clinical studies involving a 2 mg intranasal dose of epinephrine. These trials, supplemented by numerous pilot and supportive studies, confirmed that neffy met all clinical endpoints and demonstrated pharmacokinetic and pharmacodynamic profiles comparable to approved epinephrine injection products. The clinical trials involved both self-administration and caregiver administration in different patient groups, including adults, children, and those with allergic rhinitis. Adverse events reported were generally mild, with no serious nasal irritation or pain.

Dr. Jonathan Spergel of the Children's Hospital of Philadelphia highlights the significance of a needle-free epinephrine option, noting that many patients hesitate or delay using needle-based injections. The availability of a nasal spray could mitigate this hesitation, promoting quicker administration and potentially improving outcomes.

In its commitment to ensuring patient access, ARS Pharma has established various support programs. Patients with commercial insurance that covers neffy can expect to pay no more than $25 per prescription, thanks to ARS Pharma's co-pay savings program. For those without insurance or facing high out-of-pocket costs, the company offers a cash price of $199 for two doses through BlinkRx and GoodRx. Additionally, ARS Pharma's Patient Assistance Program will provide neffy at no cost to eligible uninsured or underinsured U.S. residents.

Dr. Lou Garrison from the University of Washington underscores the societal value of neffy, likening it to the peace of mind offered by having a fire extinguisher at home. He notes that beyond its immediate life-saving potential, neffy provides significant reassurance to patients and their families.

Patient support through the neffyconnect program is also a priority. This initiative assists patients, caregivers, and healthcare professionals with information on patient support programs, medication fulfillment services, and financial aid, thus facilitating the treatment process. ARS Pharma anticipates that most payors will finalize their coverage decisions within the next six months. In the meantime, neffyconnect will help navigate insurance requirements and potential access barriers.

The approval of neffy® is seen as a significant advancement for the food allergy community. According to Sung Poblete, CEO of FARE, this needle-free breakthrough could make it easier for patients to administer epinephrine during an anaphylactic reaction and encourages broader availability in various public settings.

The product is expected to be available in the U.S. within eight weeks of FDA approval for patients weighing 30 kg or more. Additional regulatory steps are planned, including the submission of a supplemental NDA for younger children. In Europe, neffy received a positive recommendation from the Committee for Medicinal Products for Human Use, with market authorization anticipated later in 2024.

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