OxyContin Abuse Deterrent Formulation Voted Beneficial By FDA Panel, But Questions Remain
Label change is one option after US advisory committee review of Purdue’s postmarketing studies concludes reformulated OxyContin ‘meaningfully reduced abuse’ by non-oral routes, but finds there is not evidence to show such reduction via all routes or that ADF reduced risk of opioid overdose.
You may also be interested in...
Purdue’s postmarketing studies leave many unanswered questions about reformulated OxyContin, including the ‘million-dollar’ question of its impact on addiction. Advisory committee members ask for clarity on what constitutes ‘meaningful reduction’ in abuse and advise FDA on what to tell the public about the data.
Arbor Pharmaceuticals’ ADHD drug faces a challenging advisory committee after FDA questions whether even an effective abuse-deterrent stimulant formulation could produce a public health benefit. And the agency isn’t convinced that Arbor’s 505(b)(2) application for its immediate release amphetamine formulation has in fact demonstrated it would reduce abuse and misuse.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.