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BioWorld - Friday, December 19, 2025
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Home » More 'Pain' for Remoxy, as adcom members vote 14-3 against approval
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More 'Pain' for Remoxy, as adcom members vote 14-3 against approval

June 28, 2018
By Jennifer Boggs
Is a fourth complete response letter (CRL) in the works for embattled pain drug Remoxy ER? Wall Street seemed to think so, sending shares of developer Pain Therapeutics Inc. (NASDAQ:PTIE) down 71.5 percent to close Wednesday at $2.44, the day after a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-3, recommending against approval of the abuse-deterrent, extended-release, oral formulation of opioid drug oxycodone.
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