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Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER

 
• By Joseph Haas

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.

CEO Remi Barbier tried to assure investors on a March 21 call that, after three previous complete response letters, Pain Therapeutics Inc. has an agreement with the US FDA on a path forward for an abuse-deterrent claim for Remoxy – and that the agency will take another look at a pre-NDA meeting to determine whether the additional data are sufficient to hopefully make it through on their fourth submission.

Barbier outlined a clinical trial intended to assess potential for intranasal abuse of Remoxy – an extended-release formulation of oxycodone...

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