Pfizer announced that, having achieved technical milestones related to manufacturing, it will continue the development program for Remoxy Extended-Release Capsules CII. Following guidance received from the U.S. Food and Drug Administration 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.
- Health Care Industry