AcelRx Announces an Investigator-Initiated Study of DSUVIA® in Patients Undergoing Plastic Surgery Procedures

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Feb 17, 2021, 08:30 ET

REDWOOD CITY, Calif., Feb. 17, 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 agreement with Newport Plastic and Reconstructive Surgery Associates for an investigator-initiated study analyzing data from the historical use of DSUVIA (sufentanil sublingual tablet 30 mcg) for various same-day plastic surgery procedures.

The principal investigator, Dr. Hisham Seify, is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons. The study will focus on the efficacy and safety of DSUVIA for use in general anesthesia plastic surgery cases, and "awake" cosmetic procedures performed at Newport Plastic and Reconstructive Surgery's center. Data from a total of 70 patients will be evaluated for endpoints which will include the utilization of DSUVIA (number of doses, timing of doses), overall amount of opioid utilized, use of other concomitant medications, vital signs, adverse events, length of surgery and time in recovery.

"We are very interested in analyzing data from patients that were administered DSUVIA across all types of plastic surgery procedures. We have used DSUVIA for over a year in a wide variety of cases and there are no currently published studies focusing on plastic surgery with this sublingual analgesic, which has been a major evolution for our practice," said Dr. Seify. "Evaluating the safety, efficacy, and timing of dosing of DSUVIA for short cases in awake patients, such as liposuction, as well as for more extensive surgeries under general anesthesia, will allow other plastic surgeons to benefit from our experience," continued Dr. Seify.

"Plastic surgery has been one of the fastest growing specialties where DSUVIA is being used. Dr. Seify is a key thought-leader in this specialty and he quickly understood the potential benefits of DSUVIA for use for plastic surgical procedures," said Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx. "We look forward to the analysis and publication of his clinical data with DSUVIA as plastic surgeons are eager for alternatives to IV opioids when treating moderate-to-severe acute pain."

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 expected commencement of an investigator-initiated study, the scope of the study, and expected analysis and publication of clinical data. 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.

SOURCE AcelRx Pharmaceuticals, Inc.