AcelRx Pharmaceuticals Announces the European Launch of DZUVEO by its Partner, Aguettant

Physicians across Europe will now have access to DZUVEO®, a novel sublingual approach to acute pain management in medically supervised settings

HAYWARD, Calif., Oct. 27, 2022 /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 its commercial partner, Laboratorie Aguettant ("Aguettant"), has launched DZUVEO® (sufentanil sublingual tablet, 30 mcg), which is branded as DSUVIA® in the U.S., across Europe.

Aguettant entered into a commercial collaboration with AcelRx in 2021 and has formally launched across key European countries, except Spain, Portugal and Italy, for which commercialization is expected to begin in the first half of 2023.  Physicians across Europe will now have access to DZUVEO, a sublingual alternative to standard intravenous (IV) opioid analgesics which have undesirable pharmacokinetic and pharmacodynamic performance profiles characterized by high peak plasma concentrations and the requirement for frequent redosing.  DSUVIA/DZUVEO was designed to provide rapid analgesia via a non-invasive route and to eliminate high peak plasma levels, provide longer duration of action, and avoid dosing errors associated with IV administration.  In addition, a number of recently published U.S. studies demonstrate that a sufentanil sublingual tablet, 30 mcg administered in various medically supervised settings can lower overall perioperative opioid use, as well as shorten recovery time, compared to IV opioids.

"We are thrilled the Aguettant team has launched DZUVEO and has now made this novel product available to healthcare professionals outside the United States for the first time," said Vince Angotti, Chief Executive Officer of AcelRx. "We remain impressed with, and are confident in the expertise of the Aguettant commercial team, and believe that the recent DSUVIA growth seen over the last five quarters here in the U.S. will support the Aguettant European launch."

"Partnering with AcelRx and leveraging the knowledge they've gained while commercializing DSUVIA in the U.S. has been extremely useful while we prepared for our launch across Europe," said Eric Rougemond, CEO of Aguettant. "We're excited to now have DZUVEO as part of our product portfolio available to our existing customers.  This is a unique asset that we believe will have a profound positive impact on the management of acute pain within hospitals and other medically supervised settings," continued Mr. Rougemond.

About DSUVIA (sufentanil sublingual tablet), 30 mcg (branded as DZUVEO in Europe)
DSUVIA®, branded 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/DZUVEO was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA/DZUVEO 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. DZUVEO has been approved by the European Medicines Agency and AcelRx's European commercialization partner, Aguettant, will market the drug in Europe.

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.

There are certain regulatory aspects of DSUVIA and DZUVEO that are different in the USA and Europe. Please refer to the Summary of Product Characteristics (SmPC) of DZUVEO in the European countries concerned by the marketing of this specialty product.

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 several product candidates. The product candidates include: Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings; two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™, a regional anticoagulant for the extracorporeal circuit; and LTX-608, for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO is an approved product in Europe.

This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.

Forward-looking statements

This press release contains forward-looking statements based upon AcelRx's current expectations. 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 "potential," "believe," "expect," "expected," "anticipate," "may," "will," "enable," "should," "seek," "approximately," "intends," "intended," "plans," "estimates," "benefits," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. 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, including: (i) risks relating to AcelRx's product development activities and ongoing commercial business operations; (ii) risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for AcelRx's commercial and developmental products and technologies; (iv) risks related to AcelRx's liquidity and our ability to maintain capital resources; (v) AcelRx's ability to retaining its listing on the Nasdaq exchange; and (vi) risks relating to our ability to obtain regulatory approvals for our developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in AcelRx'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) and any subsequent public filings. 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. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

SOURCE AcelRx Pharmaceuticals, Inc.