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

Friday, October 28, 2022

AcelRx Pharmaceuticals, Inc., 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.

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