Regulatory Actions

Pain Therapeutics Receives Complete Response Letter From FDA for REMOXY(R)

Published in Medical Letter on the CDC and FDA, December 28th, 2008

DURECT Corporation (NASDAQ:DRRX) reported that Pain Therapeutics, Inc. (NASDAQ:PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY(R), 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.

According to King Pharmaceuticals, Inc. (NYSE:KG), Pain Therapeutics' commercial partner for REMOXY, 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...

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Source: Medical Letter on the CDC and FDA (2008-12-28)

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