Pfizer to continue studies for Remoxy for Pain Control
Pfizer 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, 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.
Pfizer obtained rights to Remoxy as part of its acquisition of King Pharmaceuticals, Inc. in February 2011.
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.
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