Amphastar plunges on receipt of CRL for opioid overdose drug

Amphastar Pharmaceuticals’ (Nasdaq: AMPH) stock plunged 21% to $14.57 a share on Tuesday, after the company revealed it had received a complete response letter (CRL) from the US Food and Drug Administration regarding its opioid overdose drug.

The CRL for its New Drug Application for Intranasal Naloxone, indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, identifies issues including user human factors study, device evaluation, and other items that need to be addressed before the NDA can be approved. This means the drug will not be approved in its present form. I

Amphastar's chief executive Dr Jack Zhang, stated: "While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible.”