Pain Therapeutics Inc.'s Remoxy (oxycodone controlled-release) is no stranger to FDA complete response letters (CRLs), but the company was perplexed by the new direction taken by the agency in the third CRL issued for the abuse-deterrent opioid.
The latest letter, announced Sept. 26, details new studies and data needed to support specific abuse deterrence claims for Remoxy. The letter raises "a whole new set of discussions and issues" than the prior CRLs, received in 2008 and 2011, Pain Therapeutics CEO Remi Barbier told a conference call
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