AcelRx Announces an Investigator-Initiated Study of Dsuvia in Orthopedic Patients

AcelRx Pharmaceuticals has announced an investigator-initiated study with Cleveland Clinic. The study will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.

"A recently published study and preliminary data from other open-label studies using Dsuvia in the perioperative environment suggest a substantial decline in the amount of opioids used in the PACU, and a dramatic decrease in time to discharge from the PACU with DSUVIA-treated patients compared to historical controls," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx. "By supporting investigator-initiated, double-blind studies conducted at highly respected institutions, we look to further demonstrate the benefits of DSUVIA in the intra- and post-operative environment. We also look forward to additional studies of the effectiveness, efficiency and safety of DSUVIA in settings outside the post-surgical arena. We strongly believe the findings from all of these trials will further support Dsuvia becoming a key analgesic medication for the management of acute pain in medically supervised settings.”

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.