Pain Therapeutics Draws CRL for Remoxy ER
The FDA issued a complete response letter to Pain Therapeutics in response to its marketing application for its abuse-deterrent extended-release oxycodone formulation Remoxy ER.
The agency said the company submitted insufficient data demonstrating that the benefits of the drug outweighed the risk.
Pain Therapeutics CEO Remi Barbier called the FDA’s decision “bizarre” and “an ideological judgment call.”
As a result of the letter, the company may be forced to re-focus its resources on its Alzheimer’s program.