Pfizer Inc. and Pain Therapeutics Inc. today announced they received word from the U.S. Food and Drug Administration (FDA) regarding the resubmission of a new drug application (NDA) for REMOXY® (oxycodone) Extended-Release Capsules CII.
REMOXY is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain.
In 2005, Pain Therapeutics signed an agreement with King Pharmaceuticals Inc. to develop and commercialize REMOXY. In 2008, Pain Therapeutics filed the initial NDA for REMOXY. The following year, King Pharmaceuticals assumed full control of drug development and filed a resubmission to the initial NDA in 2010.
Earlier this year, Pfizer acquired King Pharmaceuticals, thereby obtaining rights to REMOXY. The company is now working to respond and coordinate additional talks with the FDA.
“Pfizer is working to understand and address the issues in the FDA Complete Response Letter,” Olivier Brandicourt, Pfizer president and general manager of Primary Care stated in the press release. “Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html