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).

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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.

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