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AcelRx Pharmaceuticals' ZALVISO Recognized for Innovative Design with Prestigious Red Dot Award

REDWOOD CITY, Calif., June 1, 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 that ZALVISO® (sufentanil sublingual tablet system) has been selected for a Red Dot Award in the category of Product Design – Life Sciences and Medicine. The Red Dot Awards in this category are presented to products that display innovative design features that improve or enhance patient experience. ZALVISO is a drug-device combination product designed to deliver 15 mcg sufentanil in a proprietary sublingual dosage form via a novel hand-held, pre-programmed, patient-controlled analgesia system. ZALVISO was developed by AcelRx and is currently marketed in the EU through the company's licensee, Grunenthal, for the treatment of post-operative pain management.

"When designing ZALVISO, my engineering team and I took into consideration the needs of patients, nurses, and physicians, to create a System that was easy to use, designed to dispense medication to only an identified patient, and not prone to programming errors that occur with the intravenous infusion pumps," stated Anil Dasu, AcelRx Pharmaceuticals' chief engineering officer. "We are all very proud of the work that went into designing ZALVISO and are gratified to have that work recognized with a Red Dot Award."

Jan-Uwe Claas, head of marketing EU for Grunenthal, added, "Since its launch in the first half of 2016, ZALVISO's patient-focused design has garnered positive feedback from patients, who appreciate taking control over their pain, as well as from physicians who are pleased with the product's usability and the desired level of analgesia delivered. We are delighted that this product received this prize."

Dr. Pamela Palmer, co-founder and chief medical officer at AcelRx concluded, "Since ZALVISO was approved by the EMA in 2015, the positive feedback that we and our licensee, Grunenthal, have received from patients and healthcare providers who have used ZALVISO is strong evidence that a well-designed medical product can have a meaningful impact on patient care. The Red Dot Award recognizes this fusion of design, function and patient benefit. To have ZALVISO selected from more than 5,500 entries from 54 countries is truly rewarding."

About the Red Dot Awards
In order to appraise the wide scope of design in a professional manner, the Red Dot Design Award is broken down into three distinct disciplines: Red Dot Award: Product Design, Red Dot Award: Communication Design and Red Dot Award: Design Concept. The Red Dot Award is organized by the Design Zentrum Nordrhein Westfalen in Essen, Germany, and is one of the largest design competitions in the world. In 1955, a jury convened for the first time to assess the best designs of the day. The name and brand of the award were developed in the 1990s by Red Dot CEO, Professor Dr. Peter Zec. Since then the sought-after Red Dot is the revered international seal of outstanding design quality. Further information: www.red-dot.org.

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. A New Drug Application (NDA) for DSUVIA (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the United States Food and Drug Administration (FDA). A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the NDA is anticipated to convene this summer. In the EU, the European Medicines Agency (EMA) has notified the Company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has passed validation and that the scientific review of the MAA is underway.

The Company's follow on product candidate, ZALVISO® (sufentanil sublingual tablet system), is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The Company has completed enrollment in a Phase 3 clinical trial, IAP312, for which it anticipates top-line data results in mid-2017. 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.

About Grunenthal
The Grunenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. They are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, Grunenthal is committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grunenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. Altogether, the Grunenthal Group is present in 32 countries with affiliates in Europe, Latin America and the US. Grunenthal products are sold in more than 155 countries and approx. 5,300 employees are working for the Grunenthal Group worldwide. In 2015, Grunenthal achieved revenues of € 1.2 bn. More information: www.grunenthal.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, DSUVIA™ (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 and the anticipated joint advisory committee meeting; the potential approval of the DSUVIA NDA by the FDA; the European Medicines Agency (EMA) scientific review of the ARX-04 Marketing Authorisation Application (MAA); 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, the anticipated joint advisory committee meeting for DSUVIA, the EMA review of the ARX-04 MAA, and the possibility that the FDA or EMA may dispute or interpret differently clinical results obtained from the DSUVIA or ARX-04 Phase 2 and 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, including adverse events; the success, cost and timing of all development activities and clinical trials, including the additional clinical trial for ZALVISO, IAP312; the accuracy of AcelRx's estimates regarding expenses, capital requirements and the need for financing; 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 May 8, 2017. 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.

AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.)

 

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SOURCE AcelRx Pharmaceuticals, Inc.

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