Remoxy Review Leaves US FDA Wondering: Where Is The Real-World Data On ADFs?
FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.
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Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
Studies showing oxycodone could be extracted for intravenous use troubled advisory committee members, who worried it would result in the same types of adverse public health effects that led to market withdrawal of Endo’s Opana ER; panelists also were concerned about the ability to partially defeat Remoxy’s extended-release properties by chewing the product.
Arymo ER sponsor's consultants said Purdue's postmarketing data on its reformulated oxycodone establish a link between abuse-deterrent properties and reduced real-world abuse, but FDA says it disagreed with the conclusion in the context of an OxyContin labeling supplement.