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ARTICLE | Clinical News

Single-Dose Sufentanil NanoTab: Additional Phase III data

August 22, 2016 7:00 AM UTC

The open-label, U.S. Phase III SAP302 trial in 76 adult patients who presented in the emergency room with moderate to severe acute pain associated with trauma or injury showed that 30 ug sublingual ARX-04 reduced mean pain intensity from baseline to 1 hour by 2.9 points on a 0-10 numeric rating scale (NRS). Additionally, ARX-04 reduced mean pain intensity from baseline to 15 and 30 minutes by 1.1 and 1.9 points, respectively. Patients received a single dose of 30 ug sublingual ARX-04 in the first cohort (n=40) or up to 4 doses of 30 ug sublingual ARX-04 given hourly as needed for pain in the extension cohort (n=36). In the extension cohort, ARX-04 reduced mean pain intensity from baseline to 1 hour by 3.1 points. Seven patients received a second dose of ARX-04, 2 patients received a third dose and 8% of patients in the extension cohort received morphine in addition to ARX-04. ARX-04 was well tolerated with nausea, somnolence and vomiting reported as the most common adverse events. ...