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Wednesday, January 09, 2008 1:01:21 PM
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 Application for Remoxy in Q2 2008
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