AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Oper...( Study in major abdominal surgery pati...),Health

Study in major abdominal surgery patients achieved primary and secondary endpoints

REDWOOD CITY, Calif., June 29 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from the second Phase 2 clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil NanoTabs(TM) for the management of acute post-operative pain in patients requiring opioid analgesia during hospitalization. Compared to placebo, patients receiving ARX-01 Sufentanil NanoTabs for management of post-operative pain following major abdominal surgery reported statistically significant reductions in pain intensity over the 12-hour study period.

This multicenter, double-blind, placebo-controlled study included 88 patients undergoing major abdominal surgery randomized to receive either 10 mcg or 15 mcg doses of ARX-01, or placebo for post-operative pain. Study drug was administered sublingually, as needed to treat pain with a minimum re-dosing interval of 20 minutes. Patients were allowed to drop out of the study at any time. The primary efficacy endpoint was SPID-12 (a cumulative measure of the difference in pain intensity over the 12-hour study compared to baseline). Both ARX-01 10 mcg and 15 mcg treatment groups showed statistically significant reductions in pain intensity over the study period (p<0.001 for each) based on the last observation carried forward imputation method, with similar results for alternate imputation methods (worst and baseline observations carried forward). Additionally, the proportion of patients who dropped out due to inadequate analgesia, a clinically meaningful secondary endpoint, was also significantly different from placebo (p<0.001) for both treatment groups. ARX-01 was well tolerated; the most common adverse event reported was mild to moderate nausea with similar incidence between all treatment groups (including placebo). There were no serious adverse events related to study drug.

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