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AcelRx’s Pain Drug Meets Goal in Pivotal Trial
AcelRx Pharmaceuticals’s ARX-04 (sufentanil sublingual tablet, 30 mcg) met primary and secondary endpoints in a multicenter, double-blind, placebo-controlled phase III trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery.
Results demonstrated that patients receiving ARX‑04, administered via a disposable, pre-filled, single-dose applicator, experienced significantly greater pain reduction compared with placebo, as measured by the time-weighted summed pain intensity difference over the first 12 hours of treatment (SPID-12) (P < 0.001). Adverse events reported in the study were typical of opioid therapy and were similar for patients treated with ARX-04 and placebo; the most common were nausea, headache, and vomiting.
SAP301 enrolled adult patients undergoing outpatient abdominal surgery procedures at four U.S. clinical sites. Following surgery, 163 patients were randomized to receive either ARX-04 or placebo in a 2:1 ratio. ARX-04 or placebo was administered by site staff as requested by the patient, but no more than once per hour. The intent-to-treat population had an average age of 40.9 years and an average body mass index of 27.5; 68% were female). Eighty-nine percent of patients entering the study completed the 24-hour study period.
The primary endpoint of the study was the difference in the SPID-12 score of patients receiving ARX-04 compared to those receiving placebo. SPID‑12 scores were +25.8 for ARX-04-treated patients and +13.1 for placebo-treated patients (P < 0.001). The difference in pain intensity from baseline was superior for ARX-04 over placebo at the earliest time point measured (15 minutes; P = 0.002). Secondary efficacy endpoints, which will be presented at the upcoming American Society of Anesthesiologists Annual Meeting, were also superior for ARX-04 compared to placebo.
Two serious adverse events were reported during the study; both were in the placebo group and resulted in early termination of the affected patients. No patient in the ARX-04 group dropped out of the study prior to 24 hours due to an adverse event. A lower percentage of patients treated with ARX-04 dropped out of the study prior to 24 hours due to lack of efficacy compared to the placebo group (3.7% and 18.5%, respectively; P = 0.002).
Although this trial was conducted in the ambulatory surgery setting, AcelRx plans to initiate a study later this year for emergency room patients.
Source: AcelRx; September 9, 2015.