REDWOOD CITY, California, September 22, 2020 / PRNewswire / – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised environments, today announced that the The United States Army has awarded AcelRx the initial contract price of up to approximately $ 3.6 million for the purchase of DSUVIA to support a study to aid in the development of clinical practice guidelines. Orders under the contract can be filled over the next four years, as specified in the agreement, with a first purchase expected this year.
“We are delighted to receive this first contract for DSUVIA, which illustrates the continued momentum with the Ministry of Defense,” said Vince angotti, CEO of AcelRx Pharmaceuticals. “This award is in addition to expected purchases by the US military for initial stockpiling of their medical assemblies, assemblies, kits and outfits for troop deployment, as well as potential orders from other branches of the military following the DSUVIA’s recent approval on the Joint Deployment Form. We believe that DSUVIA’s unique pharmacokinetic profile, high therapeutic index and effective sublingual delivery will position it as a key option for the management of acute pain in all branches of the army, ”continued Mr. Angotti.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, approved by the FDA in november 2018, is indicated for use in adults in certified healthcare facilities under medical supervision, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia by a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a solid single strength dosage form administered sublingually via a single dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid pain reliever previously only marketed for IV and epidural anesthesia and analgesia. The pharmacokinetic profile of sufentanil when administered sublingually avoids the high peak plasma concentrations and short duration of action seen with IV administration. The European Commission has authorized the marketing of DZUVEO in Europe in june 2018 and the Company is currently in discussions with potential European marketing partners.
This press release is intended for investors only. For more information, including important safety information and a black box warning for DSUVIA, please visit www.DSUVIA.com.
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 environments. AcelRx’s proprietary, non-invasive sublingual formulation technology provides sufentanil with consistent pharmacokinetic profiles. The Company has one product approved in the United States, DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic in adult patients in certified healthcare facilities under medical supervision, and a product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the United States, is under development as an innovatively designed patient-controlled analgesia (PCA) system for the reduction of moderate to severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.
For more information on AcelRx, please visit www.acelrx.com.
This press the press release contains forward-looking statements, including, but not limited to, statements relating to the planned purchase of DSUVIA by the military and DSUVIA being positioned as a key option for the management of acute pain in all branches of the military. These and everything else beforeforward-looking statements are made in accordance with the safe harbor arrangementns of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terms such as “believes”, “expects”, “anticipates”, “may”, “will”, ” should ”,“ seek ”,“ approximately ”,“ intention ”,“ plans ”,“ estimates ”, or the negative of these words or other comparable terminology. Discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties which could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, these risks and uncertainties may include, without limitation, those described in the annual, quarterly and current reports of the Company (i.e. forms 10-K, 10-Q and 8-K ) as filed or provided with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which such statements were first made. The Company’s SEC reports are available at www.acelrx.com under the “Investors” tab. Except to the extent required by law, the Company does not undertake to publicly disclose the result of any revision of these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unforeseen events. .
SOURCE AcelRx Pharmaceuticals, Inc.