Pain Therapeutics Inc. shares PTIE, -43.57% slid 21% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has rejected its non-opioid pain treatment, Remoxy. The company said it has received a Complete Response Letter from the FDA, saying the data submitted in its new drug application "do not support the conclusion that the benefits of [REMOXY] Extended-Release Capsules outweigh the risks." Pain Therapeutics Chief Executive Remi Barbier said it was a "bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe REMOXY received an ideological judgement call that is vague in nature but conclusive in its damaging effects." The company has now initiated a strategic reorganization to be announced shortly that will refocus its efforts on its Alzheimer's disease assets. Shares have fallen 39.8% in 2018, while the S&P 500 SPX, +0.37% has gained 6.2%.
Have breaking news sent to your inbox. Subscribe to MarketWatch's free Bulletin emails. Sign up here.