AcelRx Pharma (ACRX) Stock Trading Halted Ahead of FDA Advisory Committee to Review DSUVIA NDA
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, today announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting today to review AcelRx's New Drug Application (NDA) for DSUVIA, a 30 mcg sufentanil sublingual tablet for the management of moderate-to-severe acute pain in adult patients in a medically supervised setting.
The Advisory Committee meeting is scheduled from 8:00 a.m. to 5:00 p.m. ET. The briefing materials can be found on the FDA website. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the company's NDA for DSUVIA is November 3, 2018.
Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency. The FDA is not required to follow the guidance of an advisory committee when rendering its final decisions on pending applications and other public health matters.