AcelRx Announces DSUVIA® Added to the U.S. Department of Defense's Joint Deployment Formulary
AcelRx Pharmaceuticals announced the addition of DSUVIA to the U.S. Department of Defense's Joint Deployment Formulary, enhancing military access to the drug. This milestone underscores the significance of DSUVIA in managing acute pain and reflects growing momentum for its use, supported by new data indicating improved recovery times in surgical settings. DSUVIA, approved by the FDA in November 2018, is designed for non-invasive administration, offering advantages over intravenous alternatives. AcelRx continues discussions for European marketing partnerships for its products.
- Expansion of DSUVIA's access within the military through the Joint Deployment Formulary.
- Validation of DSUVIA's role in acute pain management, enhancing its market potential.
- Recent data supporting improved recovery times for patients using DSUVIA post-surgery.
- None.
REDWOOD CITY, Calif., Sept. 14, 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. military's access to DSUVIA has been expanded with the addition of DSUVIA to the Department of Defense's Joint Deployment Formulary (JDF). The JDF is a core list of pharmaceutical products that are designated for deploying military units across all service branches.
"DSUVIA's addition to the Joint Deployment Formulary continues to validate its importance as a key option in the treatment of acute pain and represents yet another significant milestone for AcelRx," said Vince Angotti, Chief Executive Officer at AcelRx Pharmaceuticals. "DSUVIA's advancement within the military coupled with recently published data showing how DSUVIA enhances recovery times in the post-operative setting supports the increasing momentum for DSUVIA use and allows more healthcare practitioners to experience DSUVIA's unique pharmacokinetic characteristics," stated 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 use of DSUVIA by more healthcare practitioners. 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 significance of DSUVIA being added to the Joint Deployment Formulary?
When was DSUVIA approved by the FDA?
What benefits does DSUVIA offer over traditional intravenous pain management?
Is AcelRx planning to market DSUVIA in Europe?
