FDA Panel Votes on Drug/Device Combo to Treat Pain in Medically Supervised Setting

The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.

The Food and Drug Administration (FDA)’s Anesthetic and Analgesic Drug Products Advisory Committee voted in favor (10-3) of approving Dsuvia (sufentanil sublingual tablet; AcelRx) for the treatment of moderate-to-severe acute pain in adults in a medically supervised setting.

Dsuvia is an investigational, sublingual formulation of sufentanil 30mcg in a disposable, pre-filled, single-dose applicator that is administered by a healthcare professional. Sufentanil is a synthetic opioid analgesic that is 5-10 times more potent than fentanyl. As Dsuvia was “developed to address challenges with existing treatment options”, according to AcelRx, its use could apply in situations where IV access may be limited or in patients with dysphagia who are unable to take an oral drug.

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In clinical trials (N=216), treatment with Dsuvia was found to be effective across patients of different ages and BMIs. In 2 pivotal studies, the onset of analgesia, measured by differences in pain intensity and pain relief compared to baseline, occurred within 15-30 minutes.

In the meeting documents, AcelRx notes that as the product is administered by a healthcare professional and would not be available at a retail level, the risk of diversion and abuse are mitigated. Distribution of the drug would be limited to REMS-certified medical institutions and healthcare facilities that have components to control Dsuvia access, administration, and patient management.

The FDA is not bound by the Committee’s recommendation but takes it into consideration when making its decision. The Prescription Drug User Fee Act (PDUFA) target date for Dsuvia is November 3, 2018.

For more information visit Acelrx.com.