FDA Advisory Committee Favors Approval of Intranasal Epinephrine

On May 11, 2023, the United States FDA Pulmonary–Allergy Drug Advisory Committee (PADAC) favored the approval of Neffy, the first intranasal epinephrine spray for allergic reactions. The panel convened to assess the pharmacokinetics and pharmacodynamics of medication in adults and children with type 1 allergic reactions and anaphylaxis.

The panel voted in favor of approval for adults and children, with a 17:5 vote for approving the spray in pediatric patients who weigh at least 30 kg and a 16:6 vote favoring approval for adults.

“We believe our clinical data from more than 600 individuals demonstrate Neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free, and conveniently sized. We are committed to making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with using a needle-based device,” said Richard Lowenthal, o-Founder, President, and Chief Executive Officer of ARS Pharmaceuticals, in the press release.

According to the press release from ARS Pharma, Neffy was comparable to intramuscular epinephrine injections. Both versions of the medication had similar pharmacokinetics with analogous clinical responses.

Additionally, the pharmacodynamics of the nasal spray was equivalent, if not better, to the intramuscular form. The safety profile of the spray was also favorable.

Across the US, health officials estimate that 25–40 million people have type 1 severe allergic reactions; however, only 3.3 million have an up-to-date epinephrine prescription, with even fewer regularly carrying the medication. Additional insights into epinephrine use found that many people delay or do not administer it when necessary.

Creating nasal epinephrine may make the drug more accessible to a broader range of people. A more manageable and less painful administration method may make patients more willing to use it when necessary.

“Patients need options — with different administration methods — to facilitate actual epinephrine use in an emergency event,” said Carlos Camargo, MD, DrPH, Professor of Emergency Medicine, Harvard Medical School, in the announcement.

Although the recommendations by the advisory committee are not binding, they tend to be good indicators of final FDA decisions. ARS Pharma anticipates a final decision by the middle of 2023 — within the coming months.