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AcelRx launches second late-stage study of ARX-01 for treatment of acute postoperative pain

Thursday, April 12 2012 | Comments
Evidence Grade 0 What's This?
AcelRx Pharmaceuticals Inc. started a Phase III trial to evaluate ARX-01, the company's sufentanil NanoTab patient-controlled analgesia (PCA) system, for the treatment of acute postoperative pain.

AcelRx described ARX-01 as a preprogrammed, noninvasive, hand-held system that allows patients to self-dose with sublingual sufentanil NanoTabs to manage pain following surgery.

The open-label study is the second of three planned Phase III trials that will be used to support a New Drug Application for ARX-01. The first study was initiated last month.

In this second study, the efficacy and safety of the sufentanil NanoTab PCA system will be compared with the standard of care, IV PCA with morphine, in the treatment of acute postoperative pain immediately following major abdominal or orthopedic surgery. Approximately 400 adults, who will be randomized to receive ARX-01 or IV PCA with morphine, will be treated for a minimum of 48 hours after randomization. 

The study's main purpose is to demonstrate noninferiority of ARX-01 to IV PCA with morphine as determined by patient global satisfaction with the method of pain relief. 

AcelRx anticipates starting the third study in the third quarter. That study will compare ARX-01 versus placebo in treating postoperative pain following major joint replacement surgery.

Top-line study results from all three studies are expected to be available by the end of this year or early next year.

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