Abuse-Deterrent Opioids Could Gain Significant First-Mover Advantage Under FDA Guidance
This article was originally published in The Pink Sheet Daily
FDA recommends head-to-head studies against already marketed products – an unusual development policy for the agency.
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.
Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.
US FDA soliciting ideas for opioid packaging and storage technology development; workshop scheduled for December.