Pain Therapeutics Receives FDA Letter Saying NDA For Opioid Analgesic Can't Be Approved

Pain Therapeutics Inc. said Monday it received a complete response letter from the Food and Drug Administration saying its new drug application for the opioid Remoxy ER could not be approved in its present form. The company said it was evaluating the letter and plans further discussions with the FDA. Durect Corp. said it licensed to Pain Therapeutics the exclusive right to develop and commercialize Remoxy ER and other opioid analgesics utilizing its ext extended-release, abuse-deterrent technology. Shares of Pain Therapeutics and Durect have been halted for news, and are set to resume trading at 7:30 a.m. ET. Through Friday, Pain Therapeutics' stock had soared 56% year to date, while Durect shares had tumbled 23% and the S&P 500 had gained 5.9%.