Pfizer and development partner Pain Therapeutics, Inc. (PTI) received a Complete Response Letter from the FDA on the resubmission of the NDA for Remoxy (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the CRL and plans to have further discussions with FDA around them. The companies did not give any indication that the CRL would require further trials.
Remoxy is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain requiring continuous, around-the-clock opioid treatment. The drug was developed by PTI using Durect Corp.'s Oradur technology, which is designed to discourage common methods of tampering.
In 2005, King Pharmaceuticals entered into an agreement with PTI to develop and commercialize Remoxy. PTI filed the initial NDA for Remoxy in June 2008 and received a CRL that December. King assumed full control of the development of Remoxy in March 2009 and refiled the NDA in December 2010. Pfizer obtained rights to Remoxy upon the close of its acquisition of King in February 2011.
“Pfizer is working to understand and address the issues in the FDA Complete Response Letter,” said Olivier Brandicourt, Pfizer president and general manager, Primary Care. “Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”