Phase III Trial Indicates Safety of AcelRx Painkiller

A Phase III trial showed that ARX-04, developed by AcelRx Pharmaceuticals, was well tolerated for the management of acute pain in post-surgery patients, including the elderly and those with organ impairment. Approximately 2 in 3 patients had no adverse events; the most common were nausea and headache.

The study showed a reduction in pain intensity starting at 30 minutes after the first dose of ARX-04, an opioid analgesic, followed by 27, 49, and 57 percent reductions in pain intensity at 1 hour, 2 hours, and 12 hours, respectively. AcelRx plans to submit an NDA this year.

The single-arm trial enrolled 140 patients who were expected to have moderate-to-severe acute pain after surgery. Over 12 hours, the average number of ARX-04 doses administered (sufentanil sublingual tablet 30 mcg) was 3.3, similar to that for patients with normal and impaired liver function and for patients with normal and impaired renal function. The average time between doses was more than 3 hours.