AcelRx Declares Positive Phase-II Results For ARX-01 Sufentanil NanoTabs

AcelRx has reported positive results from the second phase-II clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil NanoTabs. It is to be used for the management of acute post-operative pain in patients requiring opioid analgesia during hospitalization.

Compared to placebo, patients receiving ARX-01 Sufentanil NanoTabs 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.

The current data support the previously reported positive results for ARX-01 from the first phase-II study, which evaluated the safety and efficacy of ARX-01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery.

Pamela Palmer, CEO of AcelRx, said: “The Phase 2 results from both knee replacement and major abdominal surgery studies demonstrate that a wide variety of patients experiencing moderate-to-severe post-operative pain are able to achieve significant pain relief with our non-invasive approach to patient-controlled analgesia utilizing sublingual Sufentanil NanoTabs. We are pleased with the efficacy results, as well as with the overall side-effect profile of ARX-01 which was indistinguishable from placebo in both studies.”