AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the resubmission of the New Drug Application (NDA) for Dsuvia with the US Food and Drug Administration (FDA). AcelRx anticipates that the FDA will acknowledge acceptance of the NDA within 30 calendar days of the resubmission date. AcelRx expects a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) date in the fourth quarter of 2018.
Dsuvia (sufentanil sublingual tablet, 30 mcg), known as Dzuveo in Europe, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients. A positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was recently issued recommending approval to the European Medicines Agency (EMA) for Dzuveo. A potential marketing authorization from EMA is expected in the third quarter of 2018.
"The resubmission of the Dsuvia NDA is an important milestone for the company, and is our third key milestone achieved in the second quarter," stated Vince Angotti, chief executive officer of AcelRx. "This NDA resubmission follows the successful completion of the Human Factors study and the recent receipt of a positive opinion from CHMP for Dzuveo, and it keeps us on the path towards regulatory approvals for Dsuvia in the US and for Dzuveo in Europe this year. Importantly, we believe Dsuvia has the potential, if approved, to provide a non-invasive option for moderate-to-severe acute pain and help US hospitals manage through the intravenous opioid shortage they are experiencing in their facilities today," continued Angotti.
Dsuvia (sufentanil sublingual tablet, 30 mcg), known as Dzuveo outside the United States, is designed to treat moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of Dzuveo.
Dsuvia is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the US Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.