FDA schedules Type A meeting to discuss epinephrine nasal spray

Key takeaways:

• An FDA committee recommended neffy’s approval in May.
• The FDA and ARS Pharma will discuss the FDA’s request for additional research.
• ARS Pharma has committed to conducting the requested study.

The FDA has scheduled a Type A meeting with ARS Pharma to discuss the complete response letter that the FDA previously issued to the company about its new drug application for its neffy epinephrine nasal spray.

This meeting will be held by the end of October, according to an ARS Pharma press release.

“Patients and caregivers are waiting for neffy to be approved and have expressed to us disappointment with the delay in the FDA approval,” Richard Lowenthal, MS, MSEL, cofounder, president and CEO of ARS Pharma, said in the press release.

Richard Lowenthal

In May, the FDA Pulmonary-Allergy Drugs Advisory Committee concluded a favorable benefit-risk profile and recommended the approval of neffy, which is designed to treat anaphylaxis and other type I allergic reactions.

None of the members of the committee requested a repeat dose study of the use of neffy during allergen-induced allergic rhinitis and, in August 2023, the FDA said that such a study could be completed as a post-marketing requirement.

But in September, the FDA asked ARS Pharma to assess repeat doses of neffy compared with repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions before it could support approval.

Lowenthal said that the company was surprised by the FDA’s request for an additional study, considering its previous discussions.

“It is important to remember that there are less than 5% of food allergy cases where some degree of rhinitis is present and the unmet medical need and urgent benefit of neffy in the community are for those that are unwilling to accept a prescription for an injection device or who don’t carry or use their epinephrine autoinjector when they experience an allergic reaction,” Lowenthal said.

ARS Pharma said that it is moving forward to complete the requested study and is looking forward to the Type A meeting, which it hopes will provide an opportunity to discuss the complete response letter and neffy’s pathway forward with the FDA.

“We intend to work with FDA to meet the critical need for a needle-free epinephrine treatment as quickly as possible,” Lowenthal said.

Approximately 45% of patients with severe allergy do not fill their epinephrine prescriptions, the company said. Also, more than 50% of the people who do obtain an injection device do not carry them, and 25% to 50% do not use it when serious allergic events happen.

“We are committed to meeting this unmet medical need,” Lowenthal said.