PTI's Remoxy: US FDA Panel To Weigh Intranasal Abuse Deterrence Against Oral Abuse Potential
Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased abuse potential when Remoxy is chewed compared to swallowing the drug intact.
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The latest drug development news and highlights from our US FDA Performance Tracker.
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.
Citizen petition resembles July 2016 petition targeting extended-release oxycodone products, but this time names the products it's worries about.