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AcelRx initiates Phase II pain study

AcelRx Pharmaceuticals, a developer of new therapies for the treatment of pain and other conditions, has initiated a Phase II clinical trial of its ARX-01 Sufentanil NanoTab PCA system, a drug/device combination product candidate being developed for management of acute post-operative pain in the hospital setting.

The primary objective of this open-label study is to assess the functionality of the ARX-01 system for post-operative pain management in patients undergoing unilateral knee replacement surgery.

Thomas Schreck, CEO of AcelRx, said: “We have successfully completed two placebo-controlled Phase II studies evaluating the efficacy and safety of Sufentanil NanoTabs in knee replacement and major abdominal surgery patients. Now with this third Phase II study we are validating the functionality of the handheld component of the ARX-01 Sufentanil NanoTab PCA system as we advance the ARX-01 clinical program.”