Remoxy ERTreatment for Pain
Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII
October 27, 2014 -- Pfizer Inc. 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 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.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
Source: Pfizer Inc.
Posted: October 2014
- Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy - February 5, 2019
- Complete Response Letter Issued for Remoxy - August 6, 2018
- Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER - June 26, 2018
- FDA Accepts Remoxy NDA For Review - March 1, 2018
- Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain - February 13, 2018
- Pain Therapeutics Receives Complete Response Letter for Remoxy ER - September 26, 2016
- FDA Accepts Remoxy NDA for Review - April 12, 2016
- Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration - March 29, 2016
- FDA Complete Response Letter Received for Remoxy - June 24, 2011
- Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
- King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy - December 27, 2010
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008
- Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008
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