AcelRx Announces Initiation of Second Phase 3 Clinical Trial for ARX-01, the Sufentanil NanoTab PCA System, for the Treatment of Acute Post-Operative Pain
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) today reported dosing of the first patient in the second of three planned Phase 3 studies that will form the basis of a planned New Drug Application for the Sufentanil NanoTab® PCA System, ARX-01. Utilizing a multicenter, randomized, open-label, parallel-group design, the study will compare the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of acute post-operative pain immediately after major abdominal or orthopedic surgery.
The primary objective of the study is to demonstrate non-inferiority of ARX-01 to IV PCA with morphine as determined by patient global satisfaction with the method of pain relief. Approximately 400 adult patients, randomized 1:1 to treatment with ARX-01 or IV PCA with morphine, will be treated for post-operative pain for a minimum of 48 hours after randomization. The study will be conducted at approximately 32 academic and community hospitals in the United States with top-line data expected in second half of 2012.
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