Reuters: Regulatory News: Pfizer yet to decide on Pain Therapeutics' painkiller

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Pfizer yet to decide on Pain Therapeutics' painkiller May 10th 2013, 11:43 Fri May 10, 2013 7:43am EDT May 10 (Reuters) - Pain Therapeutics Inc said Pfizer Inc, its marketing partner for painkiller Remoxy, was yet to decide on continuing to seek regulatory approval for the drug. Shares of Pain Therapeutics fell 20 percent in light trading before the bell. Shares of Durect Corp, which provided the technology used in Remoxy, fell about 13 percent. Pfizer said it appeared there was a "regulatory pathway forward" for the drug, which it discussed with the U.S. Food and Drug Administration in a meeting on March 28. However, Pfizer executive Alan Litwack said in a letter to Pain Therapeutics Chief Executive Remi Barbier that "no final decision has been made at this time" on whether to take Remoxy to commercial development. () The abuse-resistant painkiller has been rejected twice by the FDA due to concerns about its chemical make-up and production process. Pfizer said its response to the FDA's latest rejection letter in June 2011 would not be submitted to the regulator before mid-2015. The company's shares were down slightly before the bells. Shares of Pain Therapeutics and Durect Corp rose more than 40 percent last week after Pfizer said it was in talks with the FDA to find a way forward for Remoxy. Durect's technology was used to design Remoxy as a gel capsule so that it couldn't be abused by crushing it for snorting or dissolving it for injecting. Link this Share this Digg this Email Reprints

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