AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it submitted a new drug application to the FDA for its ARX-04 sublingual sufentanil tablet. The non-invasive compound has been studied as a treatment for patients experiencing moderate or severe acute pain and is administered in a medically supervised setting using a disposable, pre-filled, single-dose applicator.
The Redwood City, Calif.-based company’s NDA was supported by the sufentanil tablet’s clinical program, which included 4 clinical trials evaluating the sublingual painkiller as a treatment for acute pain in postoperative and emergency department patients. The data showed that patients treated with the sufentanil therapy demonstrated alleviation from pain as early as 15 minutes after they were dosed. Adverse events associated with treatment were similar to that of opioid therapy – nausea, headache, vomiting and dizziness.
“During my career before AcelRx, I saw firsthand the challenges of treating pain with IV opioids; and through our market research, it’s clear that my experiences were not isolated,” co-founder & chief medical officer Dr. Pamela Palmer said in prepared remarks. “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.”
“The submission of the ARX-04 NDA is a significant corporate milestone for AcelRx,” CEO Howie Rosen added. “We are in the process of completing our commercialization plans so that we will be ready for an initial pilot launch in 2017, should ARX-04 be approved by the FDA. We also are using the NDA to prepare a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a target submission date in the 1st half of 2017 and are continuing to talk with potential European partners for ARX-04.”
