Amphastar falls on CRL for intranasal naloxone

Amphastar Pharmaceuticals Inc. (NASDAQ:AMPH) dropped $4.20 (23%) to $14.20 on Tuesday after it said it received a complete response letter from FDA for Naloxone Hydrochloride 2mg/0.5mL Nasal Spray, under review for the emergency treatment of known or suspected opioid overdose. According to Amphastar, the CRL identified issues including "user human factors study, device evaluation, and other items."

The company said it will continue to offer naloxone in pre-filled syringes while it works to resolve the agency's concerns over the intranasal formulation. ...