ARTICLE | Company News
FDA again delays Remoxy's approval
September 26, 2016 7:00 AM UTC
FDA issued a complete response letter for Remoxy oxycodone from Pain Therapeutics Inc. (NASDAQ:PTIE), which was under review to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
According to Pain, the letter specifies that the company must conduct additional studies of Remoxy's potential for abuse deterrence. Pain expects it will take about a year to complete the studies. ...