AcelRx Pharma Begins Pivotal Phase 3 Trial For ARX-04 - Quick Facts

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, Monday reported dosing of the first patient in the pivotal Phase 3 study of ARX-04.

ARX-04 is a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator or SDA.

This study, SAP301, is a multi-center, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ARX-04 compared to placebo for the treatment of moderate-to-severe acute pain following ambulatory abdominal surgery.

SAP301 is expected to include around 160 adult patients, randomized 2:1 active to placebo, to be treated for up to 48 hours.

ARX-04 or placebo will be administered by site staff as requested by the patient, but no more than once per hour.

The primary endpoint of the study is to demonstrate a statistically significant difference in the time-weighted summed pain intensity difference of ARX-04 compared to placebo over a 12-hour dosing period. The study will be conducted at four sites in the U.S.