Interim analysis of Phase III trial of ARX-04 Sufentanil NanoTab drug delivery shows benefits in pain treatment- AcelRx Pharmaceuticals

AcelRx Pharmaceuticals has reported encouraging interim efficacy and safety results of the ongoing single-arm, open-label Phase III study (SAP302) of ARX-04 Sufentanil NanoTab drug delivery for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. The primary endpoint of this initial single-dose phase of the study is the time-weighted summed pain intensity difference to baseline over the first hour, or SPID1. The 40 patients who have been enrolled and treated to date in this study experienced a substantial clinical reduction in pain intensity, resulting in a SPID1 value that is similar to previous studies of sublingual sufentanil in post-operative patients.

Patients treated with one dose of ARX-04 experienced a mean decrease from baseline of 2.7 on a 0 � 10 numeric rating scale for pain intensity one hour after dosing. Adverse events were consistent with previous clinical studies, with the most frequent events, nausea and somnolence, each reported in two of the 40 patients. None of the participants to date have terminated the study early due to adverse events.

Comment: AcelRx is hoping to target its investigational non-invasive, rapid-onset analgesic for short-term treatment of pain to patients such as wounded soldiers on the battlefield, trauma victims at the site of a road-traffic accident, migraine patients in the emergency room, or for general patients in moderate-to-severe acute pain where iv access is not readily available.