Posted by Michael Wonder on 14 Nov 2018
Pain Therapeutics appeals FDA decision on Remoxy
12 November 2018 - Pain Therapeutics today announced that it has petitioned the FDA regarding a complete response letter for Remoxy issued August 2018.
The FDA and the Company have agreed to meet in-person on 31 January 2019 to discuss this matter.
Remoxy is the proposed trade name for a new type of abuse-deterrent, twice-daily, capsule gel formulation of oxycodone. Remoxy has physical/chemical properties intended to deter abuse, compared to marketed extended-release oxycodone products.
