News Release

AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing with PDUFA Date of October 12, 2017

REDWOOD CITY, Calif., Feb. 27, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) under section 505(b)(2) for DSUVIA™ (formerly ARX-04) (sufentanil sublingual tablet, 30 mcg) for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review.  The FDA has also set a Prescription Drug User Fee Act (PDUFA) date of October 12, 2017.  The PDUFA date is the target date set by the FDA to communicate its decision on the New Drug Application.

"It is truly gratifying to see years of work developing a sublingual formulation of sufentanil and conducting multiple clinical trials finally come to this stage," stated Pamela P. Palmer, MD, PhD, AcelRx's chief medical officer and co-founder. "We believe that DSUVIA will provide physicians and their patients a non-invasive treatment alternative in emergency medicine and short-stay or ambulatory surgeries for the treatment of moderate-to-severe acute pain."

The NDA for DSUVIA includes data from four trials including SAP301 and SAP202, two randomized double-blind, placebo-controlled studies, which enrolled a total of 261 patients (198 received DSUVIA) suffering with moderate-to-severe acute pain due to soft-tissue/visceral (SAP301) or musculoskeletal procedures (SAP202). In addition, the data package includes findings from SAP302 and SAP303, two Phase 3 open-label safety and efficacy studies, which enrolled a total of 216 patients with moderate-to-severe acute pain, who had either presented at an emergency department with trauma or injury or undergone various surgical procedures, respectively. The NDA includes safety results from these studies as well as from 323 patients enrolled in the ZALVISO (sufentanil sublingual tablet system) clinical program who had dosed the first two 15 mcg doses within approximately 20 minutes, as bioequivalence was established between this regimen and a single dose of 30 mcg DSUVIA.  In total, the safety data base for DSUVIA includes over 900 patients.

The FDA has also communicated to AcelRx that it plans to hold an Advisory Committee meeting to review the DSUVIA application. The date of this meeting is yet to be determined.  

Clinical and Rehabilitative Medicine Research Program (CRMRP)
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) 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).

About DSUVIA (Formerly ARX-04) 
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).

DSUVIA is an investigational treatment and not currently available for patient use. 

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. An NDA for DSUVIA (sufentanil sublingual tablet, 30mcg) with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2017.

The Company's follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting, is currently enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun.

For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

Forward-Looking Statements 
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, DSUVIATM (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial results; AcelRx's pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for DSUVIA, ARX-04 and ZALVISO. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA and the possibility that the FDA may dispute or interpret differently clinical results obtained from the DSUVIA Phase 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process; the success, cost and timing of all development activities and clinical trials; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 2, 2016. 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.

 

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SOURCE AcelRx Pharmaceuticals, Inc.

Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com, OR Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com