AcelRx Pharmaceuticals has submitted a New Drug Application for ARX-04 (sufentanil sublingual tablet, 30 mcg) to the U.S. Food and Drug Administration.
The ARX-04 NDA was submitted under section 505(b)(2) for the treatment of patients who are experiencing moderate-to-severe acute pain in a medical setting.
"During my career before AcelRx, I saw first-hand the challenges of treating pain with IV opioids; and through our market research, it's clear that my experiences were not isolated," AcelRx co-founder and Chief Medical Officer Dr. Pamela Palmer said. "Even today, needs exist for non-invasive, cost-effective pain management in the emergency room, ambulatory surgical center, pre-hospital care, battlefield, and other diverse medical settings. We believe that ARX-04, with its sublingual delivery, could offer physicians and nurses a valuable treatment option in the treatment of moderate-to-severe acute pain."
Results from the entire ARX-04 clinical program were contained in AcelRx’s NDA. This includes the data from four ARX-04 clinical studies where the drug was evaluated to treat moderate-to-severe acute pain in patients who were in postoperative and emergency settings.
Patients taking part in the trial began to see improvement in their pain as early as 15-30 minutes after being dosed.