FDA Rejects Opioid Painkiller For The 4th Time

Law360 (August 6, 2018, 4:57 PM EDT) -- Pain Therapeutics Inc. and Durect Corp. said Monday that the U.S. Food and Drug Administration once again had refused to approve its opioid painkiller Remoxy ER, calling the agency's fourth decision to turn down the drug "bizarre" in light of the ongoing opioid crisis.

Pain Therapeutics said that the FDA had issued a complete response letter for Remoxy ER, an abuse-deterrent, extended-release form of oxycodone. In the letter, the FDA said that the data submitted in Pain Therapeutics' new drug application didn't support the conclusion that the drug's benefits outweighed its risks.

"This is a bizarre conclusion to reach, especially during...

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