Where Is OxyContin Abuse Deterrent Data? Purdue Has Sent Two Studies, But Wait Continues
US FDA expects to receive two more postmarket studies this year, but Purdue has not yet decided if it will resubmit a supplemental NDA. Consortium of 13 companies have completed six additional studies on extended-release opioids.
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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.
Abuse-deterrent formulations have been polarizing in the opioid space; now the US FDA wants feedback on developing the formulations for central nervous system stimulants, such as ADHD drugs, which could renew debate about the value of the formulations and how the agency should weigh public health considerations when deciding whether to approve an individual product.
In its continuing efforts to diversify away from opioid pain drugs, Purdue partners on non-opioid program with Alivio. Rigel licenses Tavalisse rights in all indications go to Spain’s Grifols.