FDA sets advisory committee date for Pain's Remoxy

Pain Therapeutics Inc. (NASDAQ:PTIE) said an FDA advisory committee will meet on June 26 to discuss an NDA for Remoxy ER oxycodone extended release (PF-00345439) to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Its PDUFA date is Aug. 7.

In September 2016, FDA issued a complete response letter for Remoxy citing the need for additional abuse-deterrence studies. The agency previously issued complete response letters for the product in 2008 and 2011 (see BioCentury, Oct. 3, 2016 & Jan. 12, 2018)...