Pfizer Inc. (NYSE:PFE) has notified Pain Therapeutics, Inc. (NASDAQ: PTIE) 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 has 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 U.S. Food and Drug Administration (FDA). Pfizer and Pain Therapeutics, Inc. will work together for an orderly transition of REMOXY to Pain Therapeutics, Inc. Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date.
Pfizer supports the appropriate use of opioid pain medications, and believes that abuse-deterrent products are important to help address the growing public health problem of opioid abuse in the U.S.
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