AcelRX submits FDA application for pain-reducing drug

AcelRX Pharmaceuticals recently submitted a new drug application to the U.S. Food and Drug Administration for ARX-04.
AcelRX completed a clinical trial for ARX-04, a product for patients experiencing moderate-to-severe acute pain in a medical setting, and saw promising results. Patients who took part in the study began to see improvement in their pain levels within 15 to 30 minutes of being dosed.
"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 in a statement.
Palmer noted that there is still a heavy demand in various health care settings – emergency rooms and ambulatory surgical centers among them – for non-invasive, cost-effective pain management.
"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,” Palmer said.
 AcelRX is submitting the FDA application under section 505(b)(2).