FDA advisory committee votes in support of epinephrine nasal spray for anaphylaxis

Key takeaways:

• The neffy nasal spray treats type 1 allergic reactions including anaphylaxis.
• Pharmacokinetic and pharmacodynamic responses were comparable with injection.
• The safety profile was comparable with injection.

The U.S. FDA Pulmonary-Allergy Drug Advisory Committee said available data support a favorable benefit-risk assessment for ARS Pharmaceuticals’ neffy nasal spray in treating anaphylaxis in adults and in children who weigh at least 30 kg.

Votes included 16-6 for adult use and 17-5 for pediatric use in treating type 1 allergic reactions, according to an ARS Pharmaceuticals press release, following a review of clinical studies developed in agreement with the FDA.

For example, pharmacokinetic data including epinephrine levels in blood for administration with neffy and intramuscular injection were comparable, including during the first 10 to 20 minutes when clinical response was observed.

Also, neffy had comparable or greater pharmacodynamic responses including systolic blood pressure and heart rate compared with intramuscular injection even after 1 minute of dosing, according to the press release.

“The effects of epinephrine on blood pressure and heart rate are surrogates for efficacy and are important in determining if someone is responding to treatment,” Carlos Camargo, MD, DrPH, professor of emergency medicine at Harvard Medical School, said in the press release.

Camargo also said that neffy’s effect on blood pressure and heart rate were comparable with that achieved with a single dose with an EpiPen (Pfizer) autoinjector and that its increases in systolic blood pressure were statistically higher with a second dose than they were with EpiPen, which Camargo called crucial for patients who need additional medication for severe allergic reactions.

Intranasal delivery and pharmacodynamic response also were effective even with nasal congestion or a runny nose, such as when patients are experiencing allergic rhinitis or an upper respiratory tract infection, according to the press release.

The studies further indicated that neffy’s safety profile was comparable with injection, with mild reactions that did not include any meaningful nasal irritation or pain and without any risks related to needles, the company said.

The FDA additionally already has approved neffy’s sprayer device for drug delivery in six other products, many of which are intended for emergency use.

The committee’s recommendations are nonbinding, but the FDA will consider them as it reviews the pending new drug application for neffy. The FDA has assigned a prescription drug user fee act target action date anticipated mid-2023. ARS Pharmaceuticals reported that neffy would be the first noninjectable treatment for type 1 allergic reactions, including anaphylaxis, if approved.