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 – as well as a non-clinical trial the company will conduct to evaluate whether exposure to household solvents or other environmental factors could render the drug viable for abuse by injection
