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King Pharma, Pain Therapeutics to Resubmit Remoxy

By Pharmaceutical Processing | July 7, 2009

NEW YORK (AP) — King Pharmaceuticals Inc. and partner Pain Therapeutics Inc. expect to resubmit an application for the pain drug candidate Remoxy with the Food and Drug Administration in the middle of 2010. In December, regulators delayed a decision on Remoxy and requested more data on the drug candidate. Remoxy is a form of the drug oxycodone, which is sold by Purdue Pharma LP under the name OxyContin. Remoxy tablets include the drug in a thick liquid form, which the drug developers say makes it “abuse resistant” because abusers can’t get a high from the drug by crushing or dissolving it in alcohol, which can defeat a time-release mechanism. Cupertino, Calif.-based Durect Corp. developed the “abuse-resistant” technology. Bristol, Tenn.-based King and San Mateo, Calif.-based Pain Therapeutics have been partners since 2005 in a deal to develop and sell pain treatments. In a statement, King Pharmaceuticals and Pain Therapeutics said they met with FDA representatives on July 2 and now have a clear path forward to resubmit the Remoxy application and address all FDA comments.

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