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AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, has recently announced that the US Food and Drug Administration (FDA) has conditionally accepted the brand name, Dsuvia (sufentanil sublingual tablet, 30 mcg), for the company's investigational product candidate, ARX-04. In addition, AcelRx has applied to the US Patent and Trademark Office to obtain federal registration of the Dsuvia mark.
AcelRx has announced the submission of a New Drug Application (NDA) with the FDA for Dsuvia for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting. This market is comprised of the adult emergency department setting, ambulatory and outpatient surgical settings, short-stay inpatient settings and certain office settings that serve patients undergoing painful procedures. In total, based on internal market research and published national surveys, AcelRx expects the peak market for Dsuvia in the US to be an estimated $1.1 billion.
"Our initial target market will be the emergency medicine market," commented Gina Ford, AcelRx's vice president of commercial strategy. "Pending a favorable review by the FDA, we anticipate initiating a pilot launch program into identified centers of excellence around the country shortly after approval. During the next three quarters, we plan to add the necessary commercial staff and infrastructure to support these initial commercialization efforts."
The FDA is expected to determine by mid-February 2017 whether the Dsuvia NDA is complete and acceptable for review. Should the Agency accept the NDA for review, a Prescription Drug User Fee Act (PDUFA) decision could be expected in the fourth quarter of 2017.
Dsuvia is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites. Dsuvia is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC). 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).
