AcelRx Pharmaceuticals Stock Trading Halted; FDA Advisory Committee to Review DSUVIA New Drug Application
Published: Oct 12, 2018
REDWOOD CITY, Calif., Oct. 12, 2018 /PRNewswire/ -- 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.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The company has two product candidates in the United States including DSUVIA™ (sufentanil sublingual tablet, 30 mcg), with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and Zalviso® (sufentanil sublingual tablet system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in hospitalized patients. DZUVEO™, as DSUVIA is known in Europe, and Zalviso are both approved products in Europe.
For additional information about AcelRx, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:ACRX