FDA Rejects Nasal Spray Alternative to EpiPen, Requests Further Research
The U.S. Food and Drug Administration (FDA) has declined to approve Neffy, a needle-free nasal spray alternative to the EpiPen developed by ARS Pharma, citing the need for further study. Neffy, which would have been available by prescription, is intended to treat severe allergic reactions. The FDA stated that they require more evidence to support approval, and ARS Pharma will have the opportunity to conduct additional studies and reapply for approval. Following the news, ARS shares fell by approximately 58% in pre-market trading.