Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for ...( CUPERTINO Calif. Dec. 6 /- DURECT...),Health

CUPERTINO, Calif., Dec. 6 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the pivotal Phase III trial for Remoxy had successfully met its primary endpoint (p<0.01) that was prospectively defined by the U.S. Food and Drug Administration (FDA) during the Special Protocol Assessment process. Remoxy, an investigational drug based on DURECT's patented ORADUR(TM) technology, is an abuse-deterrent version of long-acting oxycodone, a powerful painkiller available only by prescription. Remoxy is intended to meet the needs of physicians or pharmacists who appropriately prescribe or dispense long-acting oxycodone and who seek to minimize the risks of abuse, misuse or diversion. These successful results were reported today by Pain Therapeutics (Nasdaq: PTIE) and King Pharmaceuticals (NYSE: KG); Pain Therapeutics is DURECT's licensee of the rights to this investigational drug, and they in turn have sublicensed the commercialization rights to King Pharmaceuticals. According to Pain Therapeutics and King Pharmaceuticals, the FDA has agreed in writing that a single Phase III pivotal study is needed to support the regulatory approval of Remoxy. As a result, Pain Therapeutics has stated that they expect to file a New Drug
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