RemoxyTreatment for Pain
Complete Response Letter From FDA for Remoxy
Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy
SAN MATEO, Calif., December 11, 2008 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy, an abuse-resistant controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form.
The FDA believes additional non-clinical data will be required to support the approval of Remoxy. The FDA has not requested or recommended additional clinical efficacy studies prior to approval.
Pain Therapeutics, its commercial partner, King Pharmaceuticals, Inc. and outside technical advisors are evaluating the FDA Complete Response Letter, will discuss the Letter with the FDA, and will provide an update when appropriate.
Pain Therapeutics and King Pharmaceuticals remain diligently committed to their strategic alliance to develop and commercialize Remoxy and other abuse-resistant pain medications.
Remoxy, an investigational drug, is a unique, abuse-resistant controlled-release oxycodone for moderate-to-severe chronic pain. Remoxy's high viscosity, liquid formulation in a hard gelatin capsule is designed to resist common methods of misuse and abuse.
In 2005, Pain Therapeutics and King entered into a strategic alliance to develop and commercialize Remoxy and other abuse-resistant opioid painkillers. Pain Therapeutics is substantially responsible for drug formulation, clinical development and regulatory filings for Remoxy and other abuse-resistant opioid painkillers developed under this alliance. Upon regulatory approval, King will assume sole control of and worldwide responsibility to exclusively commercialize Remoxy and other abuse-resistant opioid painkillers. Pain Therapeutics retains all development and commercial rights in Australia and New Zealand. Drug candidates developed under this alliance are unique formulations of the patented Oradur(TM) technology licensed from Durect Corporation .
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the Company has four drug candidates in clinical programs including, PTI-202, PTI-721, Oxytrex(TM) and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. Pain Therapeutics is also working on a new treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of the Company's drug candidates. For more information, please visit www.paintrials.com.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products that complement the Company's focus in specialty-driven markets, particularly neuroscience, hospital and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market.
CONTACT: Christi Waarich, Senior Manager of Investor Relations of PainTherapeutics, Inc., +1-650-645-1924; or James E. Green, Esq. ,Executive Vice President, Corporate Affairs of King Pharmaceuticals, Inc.,+1-423-989-8125
Web site: http://www.paintrials.com/
Ticker Symbol: (NYSE:KG),(NASDAQ-NMS:PTIE)
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Posted: December 2008
- 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
- Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII - October 27, 2014
- 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 and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy - June 10, 2008