AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the treatment of acute and breakthrough pain, has dosed the first subjects in a phase II, placebo-controlled, dose-finding study of its ARX-04 sufentanil NanoTab product candidate.
The study will enroll approximately 100 patients following bunionectomy surgery, randomized into one of three groups: 20mcg sufentanil NanoTab, 30mcg sufentanil NanoTab or placebo, administered by healthcare personnel, as needed every hour. The study will evaluate the ability of sufentanil NanoTabs to manage moderate-to-severe acute pain over the first 12 hours following bunionectomy, and correlate the pain response with sufentanil pharmacokinetics.
AcelRx is conducting the study with funding provided by a grant from the U.S. Army Medical Research and Materiel Command (USAMRMC).
"ARX-04, a single-dose applicator containing a single sufentanil NanoTab, represents a promising new application of our proprietary NanoTab technology for sublingual delivery of sufentanil by healthcare personnel, and has the potential to safely provide rapid onset of analgesia for patients in acute pain, both on the battlefield and in civilian settings of trauma or injury," said Richard King, AcelRx's president and CEO.