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AcelRx Announces an Investigator-Initiated Study of DSUVIA® in Cardiac Surgery Enhanced Recovery Regimen
"We look forward to evaluating DSUVIA as part of our cardiac surgery enhanced recovery program which is aiming to better prepare our enrolled subjects for the stress of heart surgery by using contemporary preoperative adjuncts, educational tools, intraoperative monitoring techniques and, importantly, actively reducing the exposure of these patients to IV opioids and their side effects," states the study's co-investigator Dr.
"This investigator-initiated study at UH Cleveland presents another opportunity to assess the benefits of DSUVIA compared to IV opioids," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "The physicians at
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.
For additional information about AcelRx, please visit www.acelrx.com.
This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study and the scope of the study, expected findings from the investigator-initiated study and other studies, and the expected commencement of additional studies. 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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Raffi Asadorian, CFO, AcelRx, 650-216-3511, firstname.lastname@example.org; Brian Korb, Solebury Trout, 646-378-2923, email@example.com