The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials

Additional secondary endpoints will be measured out to Week 52, including knee stiffness and function, change in knee pain, quality of life measures and patient global impression of change for the treated knee OA.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Pain Therapeutics Inc. News release: Complete response letter issued for Remoxy. 2018 Aug 6.
2. Pain Therapeutics Inc. News release: Pain Therapeutics announces results of FDA advisory committee meeting for Remoxy ER. 2018 Jun 26.
3. Pain Therapeutics Inc. News release: Complete response letter for Remoxy. 2016 Sept 26.
4. Centrexion Therapeutics Corp. News release: Centrexion Therapeutics announces first patient dosed in phase 3 trial of CNTX-4975 for the treatment of moderate to severe knee osteoarthritis pain. 2018 Feb 21.