OxyContin Abuse-Deterrent Postmarketing Data Are In. Now What?
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.
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Members of House Energy & Commerce Committee reiterate concerns that 2001 label revision may have been used to help promote higher dosage and longer-term prescriptions of OxyContin. J&J boosts opioid litigation settlement offer to $5bn.
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.
FDA recommends head-to-head studies against already marketed products – an unusual development policy for the agency.