ACELRX: Announces Agreement for an Investigator-Initiated Study of DSUVIA® in Patients Undergoing Spine Surgery

AcelRx Pharmaceuticals, Inc. issued the following announcement on March 6.

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 Brigham and Women's Hospital for an investigator-initiated study led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School.  The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.  Perioperative use of DSUVIA in a prospective cohort of patients undergoing spine surgery will be compared to historical controls.  Analysis will include whether DSUVIA is associated with a reduction in: pain intensity in the recovery room, opioid consumption, number of IV fentanyl boluses, opioid-induced side effects, and hospitalization costs.

"An important part of our post-approval research strategy is to obtain data from top-tier hospitals about the effectiveness of DSUVIA in minimizing IV opioid administration while maintaining an effective level of analgesia for the patient," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. "By supporting investigator-initiated studies by highly respected institutions, such as Brigham and Women's Hospital, we look to further test the effectiveness, efficiency and safety of DSUVIA in a wide variety of patients as well as its unique pharmacokinetic profile and non-invasive route of administration.  We believe DSUVIA will soon become a key analgesic medication in the healthcare practitioners' armamentarium for the management of acute pain in medically supervised settings," continued Dr. Palmer.

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.

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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.

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AcelRx Pharmaceuticals, Inc. 351 Galveston Dr Redwood City, CA 94063