AcelRx Awarded U.S. Army Contract for DSUVIA®

Rhea-AI Summary

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) has secured a contract of up to $3.6 million from the U.S. Army for its product DSUVIA. This contract aims to support a study for developing clinical practice guidelines. Orders may be fulfilled over four years, with an initial purchase expected within the year. AcelRx anticipates additional orders for troop deployments following DSUVIA’s approval for the Joint Deployment Formulary. DSUVIA is indicated for managing severe acute pain in medically supervised settings, highlighting its unique sublingual delivery and pharmacokinetic profile.

Positive

• Secured a $3.6 million contract with the U.S. Army for DSUVIA.
• Initial orders expected, with potential for further purchases over four years.
• Increased credibility with military branches following DSUVIA's inclusion in the Joint Deployment Formulary.

Negative

• None.

REDWOOD CITY, Calif., Sept. 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 settings, today announced that the U.S. Army has awarded AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines.  Orders under the contract may be fulfilled over the next four years as specified in the agreement, with an initial purchase expected this year.

"We are excited to receive this initial contract award for DSUVIA, which exemplifies the continued momentum with the Department of Defense," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "This award is in addition to expected purchases from the U.S. Army for the initial stocking of their medical assemblages, sets, kits and outfits for troop deployment, as well as potential orders from other branches of the military following the recent approval of DSUVIA onto the Joint Deployment Formulary.  We believe that DSUVIA's unique pharmacokinetic profile, high therapeutic index, and efficient sublingual delivery will position it as a key option for acute pain management across all branches of the military," 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 medically supervised healthcare settings, 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 via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

This release is intended for investors only. For more information, including important safety information and 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 settings.  AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., 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 for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso^® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

For additional information about AcelRx, please visit www.acelrx.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the expected purchasing of DSUVIA by the military and DSUVIA being positioned as a key option for acute pain management across all branches of the military.  These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements.  In addition,  such risks and uncertainties may include, but are not limited to, those described in the Company's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date 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 undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

 

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SOURCE AcelRx Pharmaceuticals, Inc.

FAQ

What is the contract value awarded to AcelRx Pharmaceuticals for DSUVIA?

AcelRx Pharmaceuticals was awarded a contract valued at approximately $3.6 million by the U.S. Army.

How long will the U.S. Army contract for DSUVIA last?

The contract for DSUVIA may be fulfilled over a period of four years.

What is DSUVIA and its use in the military?

DSUVIA is a sublingual tablet used for managing severe acute pain in medically supervised healthcare settings, now included in the U.S. Army's Joint Deployment Formulary.

What potential does AcelRx see for DSUVIA in military settings?

AcelRx believes DSUVIA will serve as a key option for acute pain management across all branches of the military.