Specialist pharmaceutical company AcelRx Pharmaceuticals Inc (Nasdaq:ACRX) said on Friday that the US Food and Drug Administration (FDA) has recommended the approval of DSUVIA for the management acute pain.

The US Food and Drug Administration (FDA) anesthetic and analgesic drug products advisory committee has voted ten-three in favour of recommending the approval of the company's DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients.The Prescription Drug User Fee Act (PDUFA) date is 3 November 2018.

DSUVIA, which is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional, has been developed to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018, added the company.

According to the company, DSUVIA's recommendation was based on the safety data from two randomised, placebo-controlled studies with a total of 261 patients and two open-label, single-arm studies with a total of 216 patients. In these clinical trials, DSUVIA was shown to be well-tolerated and demonstrated efficacy across a range of patient ages and BMIs as a non-invasive analgesic for the management of moderate-to-severe acute pain.

DSUVIA is funded in part by the Clinical and Rehabilitative Medicine Research Programme (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046, concluded the company.