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Opioid Abuse-Deterrence: Immediate Release Formulation Is Chance For US FDA To Reassess Goal Posts

 
• By Michael Cipriano

Inspirion's RoxyBond would be first immediate-release oxycodone with abuse deterrent properties, and it seems backed by solid data, but first it needs to make it past two advisory committee all too familiar with the law of unintended consequences.

The US FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committees will convene April 5 to assess what would be a milestone in efforts to reduce misuse of prescription opioids: Inspirion Delivery Sciences LLC's RoxyBond (oxycodone hydrochloride) could become the first immediate-release product approved with abuse-deterrent language in the labeling. The agency and its advisors, though, may be more than a little wary of the march of progress in this particular area, given that advances have seemed to move in lock step with unintended consequences.

There are currently nine FDA-approved opioids with abuse detterent language, all extended release. ER formulations are generally more attractive for...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.