AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported dosing of the first patient in the pivotal Phase 3 study of ARX-04. ARX-04 is a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator (SDA).
This study, SAP301, is a multi-center, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ARX-04 vs. placebo for the treatment of moderate-to-severe acute pain following ambulatory abdominal surgery. SAP301 is expected to include approximately 160 adult patients, randomized 2:1 active to placebo, to be treated for up to 48 hours. ARX-04 or placebo will be administered by site staff as requested by the patient, but no more than once per hour. The primary endpoint of the study is to demonstrate a statistically significant difference in the time-weighted summed pain intensity difference (SPID) of ARX-04 compared to placebo over a 12-hour dosing period (SPID-12). The study will be conducted at four sites in the United States.
"We are pleased to have our pivotal ARX-04 Phase 3 clinical trial underway. The ARX-04 product represents a promising new application of our sublingual tablet technology for delivery of sufentanil and has the potential to safely provide non-invasive, fast-acting analgesia for patients in acute pain," stated Dr. Pamela Palmer, AcelRx's founder and Chief Medical Officer. "We anticipate enrollment to take up to nine months. Pending the completion of enrollment in this study, we anticipate top-line results in the fourth quarter of 2015."
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