The US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee (PADAC) voted in favor of a new intranasal epinephrine treatment known as ARS-1 (neffy) for adults and children with allergic reactions like anaphylaxis, according to an announcement by ARS Pharmaceuticals, Inc.¹

The biopharmaceutical company announced that the new ARS-1 treatment, designed to empower patients and caregivers and protect from severe allergic reactions, would be for both adults and children with a weight of over 30 kg.

If approved by the FDA in the near future, the intranasal epinephrine with its sprayer device would be considered the first non-injectable treatment made available to those with Type 1 allergic reactions such as anaphylaxis.2

The decision by the FDA’s PADAC was made due to clinical trial data that had been reviewed and included a positive risk-benefit profile for the treatments efficacy and safety compared to injection of epinephrine.

The trial data indicated that ARS-1 had comparable pharmacokinetic data and safety data, comparable or greater pharmacodynamic response, and effective systemic epinephrine delivery (even accounting for runny nose or nasal congestion), compared to intramuscular injection.

The company noted that PADAC recommendations are non-binding, but the FDA will now be including the vote in its assessment and review of the company’s pending New Drug Application (NDA). The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is planned for around the middle of 2023.

“The committee’s thoughtful review of the data, and support of the potential for neffy to address significant unmet needs of the severe allergy community, if approved, is highly encouraging,” Richard Lowenthal, president, Chief Executive Officer, and co-founder of ARS Pharmaceuticals, said in a statement.

Allergic reactions categorized as Type 1 are known to be serious and possibly life-threatening if post-exposure treatment is not administered in these cases. Epinephrine is currently known to be the only medication approved by the FDA for such reactions.

In fact, around 25 to 40 million Americans are known to experience allergic reactions in the Type 1 category, according to ARS officials, and only 3.3 million are said to carry prescriptions for active epinephrine autoinjectors.

Many patients and caregivers are known to avoid or delay treatment in emergency allergic reaction situations, due to various reasons such as needle-related concerns about safety, lack and device complexity.

“We continue discussions with private payers, pharmacy benefit managers, and retail pharmacies to ensure that if neffy receives FDA approval, we are ready to make this important new treatment modality widely available for those who need it,” Lowenthal noted in his statement.

Another nasal epinephrine spray treatment (Utuly), designed as an alternative to the epinephrine auto injector for those suffering from severe allergies, may also be submitted as an NDA for FDA approval this year.²

References

1. ^{ARS Pharmaceuticals. FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis [press release]. Published May 11, 2023. Accessed May 11, 2023. https://ir.ars-pharma.com/news-releases/news-release-details/fda-advisory-committee-votes-support-favorable-benefit-risk}
2. ^{Grossi G. David Dworaczyk, PhD: FDA Review is Anticipated for an Epinephrine Nasal Spray. HCPLive. May 9, 2023. https://www.hcplive.com/view/david-dworaczyk-phd-fda-review-is-anticipated-for-an-epinephrine-nasal-spray.}