Pfizer Ends Agreement for Extended-Release OxycodoneBy
Pifzer has notified Pain Therapeutics, Inc. that it has decided to discontinue its agreement to develop and commercialize Remoxy (oxycodone) extended-release capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics, Inc.
Pfizer said it had concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the US Food and Drug Administration (FDA). “Pfizer and Pain Therapeutics, Inc. will work together for an orderly transition of Remoxy to Pain Therapeutics, Inc.,” said Pfizer in a company statement. Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date.