FDA Sends Complete Response Letter for Pfizer Drug

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Published June 24, 2011

| FOXBusiness

Shares of Pain Therapeutics (PTIE) dropped sharply Friday after news hit that its pain drug with Pfizer (PFE) received a letter from the U.S. Food and Drug Administration requesting more information.

The complete response letter, which is often a sign the drug will not receive approval, was in response to the companies new drug application for remoxy, a controlled-release form of often abused oxycodone.

Based on Durects oradur technology designed to transform short-acting oral capsule dosage forms into sustained release products, is meant to discourage common methods of tampering.

"The misuse and abuse of pain medications is a widespread problem in this country and we will continue to support Pfizer in their efforts to address this important public health and safety issue, Durect CEO James Brown said in a statement.

Rights to develop and commercialize the investigational drug were licensed to Pain Therapeutics by Durect in 2002. Despite the letter, Pfizer said it is working to evaluate all issues and plans to have further discussions with the FDA.

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