Pfizer Inc. announced that, having achieved technical milestones related to manufacturing, it will continue the development programme for Remoxy (oxycodone) extended-release capsules CII. Following guidance received from the US Food and Drug Administration (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, in part, a pivotal bioequivalence study with the modified Remoxy formulation to bridge to the clinical data related to the original Remoxy formulation, and an abuse-potential study with the modified formulation. As previously disclosed, 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 when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Remoxy was initially developed by Pain Therapeutics, Inc. using DURECT Corporation’s Oradur technology, which is designed to discourage common methods of tampering. In 2005, King Pharmaceuticals, Inc. entered into an agreement with Pain Therapeutics, Inc. to develop and commercialize Remoxy. Pain Therapeutics, Inc. filed the initial new drug application (NDA) for Remoxy in June 2008 and received a Complete Response Letter in December 2008. King Pharmaceuticals, Inc. assumed full control of the development of Remoxy in March 2009 and filed a resubmission of the Remoxy NDA in December 2010. Pfizer obtained rights to Remoxy as part of its acquisition of King Pharmaceuticals, Inc. in February 2011.