ARS Pharmaceuticals is set to meet with the U.S. Food and Drug Administration (FDA) later this month to address the FDA's recent rejection of the company's proposed epinephrine nasal spray for the treatment of severe allergic reactions.
Despite receiving a positive recommendation from one of the FDA's advisory committees, the spray, known as "neffy," was not approved by the FDA, surprising many.
In response, the FDA has scheduled a Type A meeting to discuss the details outlined in the complete response letter sent to ARS regarding the neffy application. One of the key requirements in the letter is for ARS to complete a repeat-dose study before approval.
Type A meetings, according to FDA guidelines, are designed to resolve disputes and facilitate progress in product development programs. These meetings are typically scheduled within 30 days of receiving a written request.
Prior to the FDA's rejection, neffy was expected to be approved as the first needle-free epinephrine product for severe allergic reactions. ARS had already reached an agreement with the FDA on conducting the repeat-dose study after approval, and had planned to contest the agency's decision.
ARS is now swiftly moving forward with conducting the repeat-dose study, and is optimistic that the meeting with the FDA will provide an opportunity to discuss their position and establish a pathway forward for neffy.