FDA Issues Judgement Regarding New Innovative Epinephrine Nasal Spray
The Food and Drug Administration (FDA) has recently rejected an alternative to conventional epinephrine autoinjectors, such as the commonly used EpiPen. The alternative, a nasal spray called Neffy, was developed by ARS Pharma and was aimed to provide a needle-free epinephrine treatment for individuals with severe food allergies. However, the FDA has requested the completion of a study, despite an FDA Advisory Committee’s recommendation in May 2023 to approve neffy without further study.
The FDA’s decision has sparked disappointment and frustration among the food allergy community, which includes approximately 32 million people in the United States, according to Food Allergy Research and Education (FARE), a non-profit advocacy group. Anaphylaxis, a severe and life-threatening allergic reaction, is estimated to cause up to 200 deaths each year.
ARS Pharma, the makers of neffy, have expressed surprise and announced their plans to appeal the FDA’s decision. In a statement, Richard Lowenthal, co-founder and CEO of ARS Pharma, stated that the FDA has requested a study to assess the impact of repeat doses of neffy compared to repeat doses of injected epinephrine. Lowenthal also highlighted the benefits of neffy, including its easy administration and the absence of anxiety and hesitation often associated with using an autoinjector. Lowenthal has also stated that ARS Pharma will complete the required study as soon as possible.
Dr. Sung Poblete, CEO of FARE, also expressed disappointment with the FDA’s decision, stating that the innovative neffy would have been a game-changer for the food allergy community. She further added that the FDA’s decision would force individuals with life-threatening allergies to wait even longer for an alternative to conventional epinephrine autoinjectors.
Neffy works similarly to Narcan, the nasal spray used to reverse opioid overdoses. There is no preparation or activation required before using the device, and it is easily administered by spraying it into the nose. According to Lowenthal, neffy is absorbed by the nasal mucosa with the help of a solvent, making it an effective alternative to injecting epinephrine. The studies presented to the FDA showed that neffy performed similarly to injected epinephrine. The most reported side effects included mild nasal discomfort, headache, runny nose, nausea, dizziness, vomiting, and mild throat irritation.
According to Christine Creter, whose 12-year-old son has multiple food allergies, neffy would have been much easier to administer compared to conventional epinephrine autoinjectors. Training is not required to operate neffy, which could make it more accessible in settings such as schools, airplanes, and first-aid kits.
The rejection of neffy by the FDA highlights the need for alternative treatments for severe allergic reactions. The survey published in the Annals of Allergy, Asthma, and Immunology found that one of the main reasons for the underuse of epinephrine autoinjectors was the fear of using an autoinjector. With neffy, individuals would not have to overcome the fear of needle injections, making it a suitable alternative for those with severe food allergies. The hope is that the completion of the required study and the subsequent approval of neffy by the FDA will provide a much-needed alternative to conventional epinephrine autoinjectors for the food allergy community.