DURECT Corporation announced today that Pfizer Inc. has stated that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY (oxycodone) Extended-Release Capsules CII. Following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer announced that they 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.
"We are pleased that, after a thorough review and having achieved technical milestones, Pfizer is proceeding with development of REMOXY," stated James Brown, President and CEO of DURECT. "We continue to believe that REMOXY could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone." In addition, Pain Therapeutics, Inc. has regained all rights from Pfizer with respect to the three other ORADUR-based opioid drug candidates (hydrocodone, hydromorphone and oxymorphone). Pain Therapeutics is now free to develop and commercialize these product candidates on its own or with a licensee. Investigational New Drug (IND) applications for these drug candidates are in place with the FDA. Pain Therapeutics has stated that they have not yet made a decision to develop or out-license the three product candidates.