FDA advisory panel approves AcelRx’s opioid pain drug Dsuvia

pharmafile | October 15, 2018 | News story | Sales and Marketing FDA, approval, comittee, opioids 

An FDA advisory panel voted 10 to 3 to recommend the approval of AcelRx Pharmaceuticals’ opioid pain drug Dsuvia (sufentanil) to manage moderate-to-severe acute pain in adults in medically supervised settings.

The go-ahead has come after the federal agency questioned the drugs superiority and raised concerns surrounding the medication’s small pill size which could lead to accidental use.

Chief medical officer Pamela Palmer commented: “We look forward to continued collaboration with the FDA on the application as we believe Dsuvia represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care.”

The decision comes after a Phase III trial conducted in 2016 suggtested that the therapy was associated with a 35% reduction in pain intensity in patients who visited the emergency room for moderate to severe pain caused by injury or trauma.

Louis Goss

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