Pfizer Continues Remoxy E-R Development

Pfizer, having achieved technical milestones related to manufacturing, will continue the development program for Remoxy (oxycodone) Extended-Release Capsules CII. Following guidance received from the FDA earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. 
 
These new clinical studies will include a pivotal bioequivalence study with the modified Remoxy formulation and an abuse-potential study with the modified formulation. The complete response submission is not expected to occur prior to mid-2015.
 
Remoxy is an investigational extended-release oral formulation of oxycodone for the management of moderate-to-severe pain. Remoxy was initially developed by Pain Therapeutics using Durect Corp.’s ORADUR technology, which is designed to discourage common methods of tampering. In 2005, King Pharmaceuticals entered into an agreement with Pain Therapeutics to develop and commercialize Remoxy. Pfizer obtained rights to Remoxy as part of its acquisition of King Pharmaceuticals, in February 2011.