An FDA advisory committee voted 10 to 3 on Friday to recommend approval of AcelRx Pharmaceuticals' Dsuvia (sufentanil) to manage moderate-to-severe acute pain in adults in medically supervised settings. Agency reviewers recently questioned Dsuvia's superiority, saying it appeared to provide no advantages over currently available treatments, and they also raised concerns about potential accidental use by others given the drug's small tablet size.
AcelRx said its FDA submission was backed by data from two randomised, placebo-controlled trials involving a total of 261 patients, as well as two single-arm studies of 216 patients. In data from the Phase III SAP302 trial unveiled in 2016, the therapy, also known as ARX-04, was associated with a 35-percent reduction in pain intensity versus baseline in patients who visited the emergency room for moderate-to-severe acute pain caused by injury or trauma.
Chief medical officer Pamela Palmer remarked "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 US regulator is expected to decide whether to approve Dsuvia, which is administered via a pre-filled single-dose applicator, by November 3.
The FDA issued a complete response letter to AcelRx for its filing last October, but accepted the company's resubmission earlier this year. The therapy was recently authorised for the treatment of acute moderate-to-severe pain in medically monitored settings in Europe, where it is marketed under the name Dzuveo.
Meanwhile, an FDA advisory committee voted 8 to 7 earlier this week against backing approval of Trevena's experimental opioid analgesic Olinvo (oliceridine) for the treatment of moderate-to-severe acute pain in adults requiring an intravenous opioid. The agency is expected to render its decision on Olinvo by November 2.
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