In a move that clearly surprised ARS Pharma, the U.S. FDA issued a CRL regarding the company's New Drug Application for epinephrine nasal spray in the treatment of allergic reactions, including anaphylaxis.
In the letter, the FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of the drug — known as neffy — compared to repeat doses of an epinephrine injection product to support approval. But this request, according to San Diego-based ARS, is a departure from an agreement reached between the company and the agency last month that stipulated the study would be conducted as a post-marketing requirement for labeling purposes.
The rejection was also unexpected considering that the FDA's Pulmonary-Allergy Drug Advisory Committee voted 16-6 in favor of approval of neffy for adults and 17-5 in favor for children back in May 2023. The committee did not state the need for additional studies to demonstrate efficacy or safety.
Now, ARS says it plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the CRL. The drugmaker anticipates a resubmission to the FDA in the first half of 2024, positioning the company for an anticipated FDA action date in the second half of 2024.
If ARS can secure approval, the drug, which is easier to carry and administer than the traditional EpiPen, would be the first-ever needle-free nasal spray epinephrine treatment for people with severe allergic reactions.
