Pain's Remoxy Skips Over Panel On Rocky Road To Market
The FDA's decision not to hold an advisory committee meeting for Pain Therapeutics Inc.'s twice-before rejected Remoxy looks to bode well for the abuse-deterrent, extended-release oxycodone product – or at least, investors thought so.
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Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.
FDA's complete response letter includes extensive list of new studies needed to support abuse-deterrence claims not featured in two prior CRLs, Pain Therapeutics says, wondering why the agency is only now raising issues that could have been discussed previously.
Pending arrival of several new products prompts evaluation of class, ICER CSO Dan Ollendorf explains; availability of both abuse-deterrent and non-abuse-deterrent drugs among challenging issues.