AcelRx Pharmaceuticals Doses the First Subjects in ARX-04 Phase 2 Study
AcelRx Pharmaceuticals (NASDAQ: ACRX) today announced that it has dosed the first subjects in a Phase 2, placebo-controlled, dose-finding study of its ARX-04 sufentanil NanoTab product candidate. This study will enroll approximately 100 patients following bunionectomy surgery, randomized into one of three groups; 20 mcg sufentanil NanoTab, 30 mcg 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, or 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