Pfizer, Pain Therapeutics receive FDA complete response letter for Remoxy

Pfizer and Pain Therapeutics received a complete response letter from the FDA with regards to a regulatory filing for the experimental abuse-resistant pain drug Remoxy (oxycodone), the companies announced Friday. Pfizer said it is working to evaluate the issues raised in the letter and will enter into further discussions with the agency.

In May, the drugmaker suggested that approval of Remoxy could be delayed because of issues with the manufacturing part of its application. However, the company didn't disclose whether the complete response letter was related to those problems. Shares in Pain Therapeutics and Durect, which originally developed the agent, fell as much as 52 percent and 29 percent, respectively, on the news.

Pain Therapeutics received a complete response letter for its initial filing for Remoxy in 2008, and filed a response in December. Pfizer gained rights to the drug through its recent acquisition of King Pharmaceuticals, which had a licensing deal with Pain Therapeutics.

[Link]

Previous page: REMS Daily Next page: REMS Events
 
Register for periodic industry updates: