The Food and Drug Administration (FDA) has refused to approve an epinephrine nasal spray called Neffy, which would have offered a needle-free alternative to epinephrine autoinjectors like EpiPens. The agency stated that further studies were necessary to support approval. This decision is surprising and unexpected, as it goes against the recommendations made by the FDA’s advisory committee, which had voted in favor of the drug’s approval for both children and adults.
Epinephrine has been used effectively in the United States since 1901 to reverse anaphylaxis, a severe form of allergic reaction that can be life-threatening. However, all existing epinephrine treatment options require injection, which can be problematic for individuals with a fear of needles. The absence of a needle-free option has been a long-standing issue, and the rejection of the epinephrine nasal spray is a disappointment for many.
One concern raised during the advisory committee meeting was the lack of clinical data, particularly the absence of studies in individuals experiencing anaphylaxis. ARS Pharmaceuticals, the drugmaker behind Neffy, claimed that the nasal spray was comparable to an EpiPen based on studies conducted in animals and individuals without anaphylaxis. However, some committee members, like Dr. Maryann Amirshahi, raised concerns about the efficacy of the drug without sufficient data.
Ethical questions arise when studying a drug intended for the emergency treatment of life-threatening allergic reactions. Conducting a randomized controlled trial in which some participants would receive a placebo instead of immediate treatment would be considered unethical. Dr. Amirshahi suggested that the drug could be studied in people experiencing anaphylaxis in allergist’s offices or emergency rooms, where fail-safe treatments are readily available.
The FDA has requested an additional study comparing Neffy to an epinephrine autoinjector in individuals with allergen-induced nasal symptoms. ARS Pharmaceuticals plans to resubmit the application to the FDA in the first half of 2024 in the hopes of eventually obtaining approval. This delay offers an opportunity to gather more data and ensure the drug’s efficacy before it is made available to the public.
Overall, the rejection of the epinephrine nasal spray is a setback for those seeking a needle-free alternative. However, further study and evaluation will be conducted to address concerns and ensure the safety and effectiveness of the drug.
– NBC News