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Dsuvia's Thumbs Up From US FDA Advisory Panel Is First Positive Vote For An Opioid In 2018

 
• By Michael Cipriano

 AcelRx's sublingual opioid fills a need for narrow population, panelists conclude, despite US FDA's concerns about tablet size and committee's own worries about efficacy.

The US FDA's Anesthetic And Analgesic Drug Products Advisory Committee voted by a 10-3 margin that the benefits of AcelRx Pharmaceuticals Inc.'s sublingual opioid Dsuvia (sufentanil) outweigh its risks, and the Oct. 12 decision seems almost as important to the product class as to the sponsor since it marks the first time this year an opioid has succeeded in getting a favorable opinion from an agency panel.

The vote may have been somewhat impacted by the narrow indication the company is seeking, which is the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative

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More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
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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.

Global Pharma Guidance Tracker - March 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.