Catalyst
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FDA Advisory Committee Votes in Favor Of DSUVIA ( (sufentanil sublingual tablet, 30 mcg) For The Treatment Of Moderate-To-Severe Acute Pain
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Additional Information
The company presented DSUVIA efficacy and safety data from two randomized, placebo-controlled studies with a total of 261 patients and two open-label, single-arm studies with a total of 216 patients. In these clinical trials, DSUVIA was shown to be well-tolerated and demonstrated efficacy across a range of patient ages and BMIs as a non-invasive analgesic for the management of moderate-to-severe acute pain.
Developed to address challenges with existing treatment options and to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes, DSUVIA is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional.
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Catalyst Date
Occurred on:
Oct 12, 2018
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Related Keywords
Dsuvia, Sufentanil Sublingual Tablet, Acute Pain