Phase II trial of ARX 04 Sufentanil NanoTabs (AcelRx Pharmaceuticals) meets endpoint for Acute Pain
Top-line results from a placebo-controlled, dose-finding, Phase II study of sublingual sufentanil NanoTab for Acute Pain, ARX 04, from AcelRx Pharmaceuticals, show that the treatment successfully met its primary endpoint. The study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms. Results demonstrated that patients receiving 30 mcg sufentanil NanoTab doses had significantly greater pain reduction as measured by Summed Pain Intensity Difference to baseline during the 12-hour study period (SPID-12) than placebo-treated patients (p=0.003). Adverse events reported in the study were generally mild-to-moderate in nature, with two serious adverse events of post-surgical infection reported.
AcelRx has announced results from two Phase III clinical trials for the NanoTab System, and a third Phase III study has completed enrollment, with data expected in the second quarter of 2013. A New Drug Application submission is planned for the third quarter of 2013.
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