AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab ...( REDWOOD CITY Calif. May 5 /- AcelRx P...),Health

REDWOOD CITY, Calif., May 5 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced that it has initiated a Phase 2 clinical trial of its ARX-01 Sufentanil NanoTab(TM) PCA System, a proprietary 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.

AcelRx Chief Executive Officer, Thomas Schreck, commented, "We have successfully completed two placebo-controlled Phase 2 studies evaluating the efficacy and safety of Sufentanil NanoTabs in knee replacement and major abdominal surgery patients. Now with this third Phase 2 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."

Study investigator David Griffin, MD, of the Orthopaedic Center of Vero Beach, Florida stated, "I am excited about ARX-01; I believe it has the potential to address a large unmet medical need in the management of post-operative pain by allowing patients to manage their pain without the need for an IV line or complicated IV PCA pumps. Seeing the smooth, uneventful initiation of this first study utilizing the ARX-01 Sufentanil PCA System adds to the already compelling Phase 2 data that AcelRx announced in December."

About Acute Post-Operative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patient-controlled analgesia (PCA), typically utilizing morphine, for inpatient post-operative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing post-operative c
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