AcelRx Announces Completion of the Human Factors Study for DSUVIA and Confirms Plans to Resubmit NDA in Q2 2018
Published: Apr 16, 2018
REDWOOD CITY, Calif., April 16, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the successful completion of the human factors (HF) study performed to validate the effectiveness of the revised DSUVIA directions for use (DFU). This study was recommended by the U.S. Food and Drug Administration (FDA) following the Company's application of FDA recommended changes to the DSUVIA DFU to ensure the safe and proper administration of DSUVIA to patients by healthcare professionals in medically supervised settings.
"The completion of the HF study was the final step required to prepare the DSUVIA New Drug Application (NDA), which we expect to resubmit in the second quarter of this year," stated Vince Angotti, CEO of AcelRx. "This study was the first of our key 2018 milestones outlined on our year-end earnings call. We remain focused on the achievement of each of these key milestones, which we believe will enable 2018 to be a transformational year for AcelRx," continued Angotti.
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 including DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as DZUVEO outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
This press release contains forward-looking statements, including, without limitation, statements related to the process and timing of an NDA resubmission for DSUVIA with the FDA, and the plan for achieving identified key milestones during the year. These forward-looking statements are based on AcelRx's current expectations and involve significant risks and uncertainties. AcelRx's actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including, without limitation: risks related to the possibility that the results of the Company's HF study may be disputed or interpreted differently by the FDA such that it results in further required action by the Company or ultimately does not support approval of the Company's planned NDA submission for DSUVIA; any delays or the inability to obtain and maintain regulatory approval of DSUVIA in the United States, DZUVEO in Europe and ZALVISO in the United States; the inability of the Company to achieve key milestones for 2018; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K filed with the SEC on March 9, 2018. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
CONTACT: Investors, Brian Korb, Solebury Trout, 646-378-2923, email@example.com, Raffi Asadorian, Chief Financial Officer, AcelRx, firstname.lastname@example.org
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SOURCE AcelRx Pharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:ACRX