Pfizer’s Troxyca ER Opioid Combo Faces Intravenous Abuse Concerns
This article was originally published in The Pink Sheet Daily
Executive Summary
More oxycodone was extracted from the combination product, potentially defeating the opioid-blunting effects of the naltrexone component and creating a hurdle to an abuse-deterrent claim.
You may also be interested in...
Restrictive REMS Is Least Favored Path For Opioid Prescriber Education
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.
Opioid Market Snapshot: No Pain, No Gain For Abuse-Deterrence Claims
Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.