AcelRx announced positive interim results from an ongoing Phase 3 study of ARX-04 for the treatment of adults with moderate-to-severe acute pain associated with trauma or injury.
The Phase 3 study (SAP302) is a single-arm, open-label trial evaluating the safety and efficacy of ARX-04 in adult patients presenting to the emergency room with trauma or injury-related moderate-to-severe acute pain. The primary endpoint of the initial single-dose phase of the study is the time-weighted summed pain intensity difference to baseline over the first hour (SPID1).
Currently, 40 patients were enrolled and treated in the study to date. Interim results showed that all 40 patients experienced a substantial clinical reduction in pain intensity, with a SPID1 value similar to previous studies of sublingual sufentanil in post-operative patients. Patients treated with one dose of ARX-04 had a mean decrease of pain intensity from baseline of 2.7 (range 0–10) 1hr after the dose.
The study is ongoing and will continue to enroll patients with a goal of up to 120 in total. The study also includes an extension arm to allow for multiple doses of ARX-04 to be given hourly, as needed, for up to 4 doses. This is expected to be initiated by the end of the first quarter of 2016.
ARX-04 is an investigational product consisting of 30mcg sufentanil tablets delivered sublingually via a disposable, pre-filled, single-dose applicator.
For more information visit Acelrx.com.