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AcelRx Announces an Investigator-Initiated Study of DSUVIA® in Patients Taking Buprenorphine Who Require a Surgical Procedure

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REDWOOD CITY, Calif., April 8, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in healthcare institutions, today announced an investigator-initiated study at Montefiore Medical Center evaluating the perioperative use of DSUVIA (sufentanil sublingual tablet 30 mcg) for same-day surgical procedures in patients on buprenorphine therapy for opioid-use disorder or for chronic pain management.

The principal investigator, Dr. Naum Shaparin, is the Interim Chair of the Department of Anesthesiology and Director of the Multidisciplinary Pain Program at Montefiore Medical Center and Professor of Anesthesiology at Albert Einstein College of Medicine. The study will evaluate the efficacy and safety of DSUVIA for perioperative management of surgical pain in patients on buprenorphine treatment. Data from a total of 30 patients will be evaluated for endpoints which include overall perioperative opioid use, length of post-anesthesia care unit recovery time, outpatient prescription opioid use over the first 24 hours after discharge home, and adverse events. Data from these patients will be compared to historical matched control patients on buprenorphine treated with standard IV opioids in the perioperative setting.

"Buprenorphine is a partial opioid agonist, but it binds with extremely high affinity to the mu-opioid receptor. When patients on buprenorphine require a surgical procedure, they need the analgesic efficacy of a full opioid agonist, but the opioids currently in use have a lower receptor binding affinity and cannot displace the partial agonist off the receptor, thereby limiting their effect," said Dr. Shaparin. "Sufentanil is unique in that it has a higher binding affinity to the mu-opioid receptor than buprenorphine, allowing DSUVIA to potentially provide these patients with more effective analgesia, " continued Dr. Shaparin. Dr. Shaparin previously served as a consultant for AcelRx and on advisory boards.

"The buprenorphine-treated patient has long posed a clinical challenge for anesthesiologists," said Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx. "Being able to provide these patients a perioperative analgesic option that may be more effective than traditional IV opioids could be yet another way for DSUVIA to advance acute pain management in medically supervised settings."

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, 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 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 expected commencement of an investigator-initiated study, the scope of the study, expected analysis of clinical data, and the potential for DSUVIA to provide buprenorphine-treated patients with effective analgesia. 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.

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