Benzinga | Apr 8, 2021 08:47AM EDT

AcelRx Announces Investigator-Initiated Study Of DSUVIA In Patients Taking Buprenorphine Who Require A Surgical Procedure

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 anAcelRx 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 investigator-initiated study at Montefiore Medical Center evaluating the perioperative use of DSUVIA (sufentanil sublingual tablet 30 mcg) for same-day surgical procedures in patients on buprenorphine therapy for opioid-use disorder or for chronic pain management.

The principal investigator, Dr. Naum Shaparin, is the Interim Chair of the Department of Anesthesiology and Director of the Multidisciplinary Pain Program at Montefiore Medical Center and Professor of Anesthesiology at Albert Einstein College of Medicine. The study will evaluate the efficacy and safety of DSUVIA for perioperative management of surgical pain in patients on buprenorphine treatment. Data from a total of 30 patients will be evaluated for endpoints which include overall perioperative opioid use, length of post-anesthesia care unit recovery time, outpatient prescription opioid use over the first 24 hours after discharge home, and adverse events. Data from these patients will be compared to historical matched control patients on buprenorphine treated with standard IV opioids in the perioperative setting.

"Buprenorphine is a partial opioid agonist, but it binds with extremely high affinity to the mu-opioid receptor. When patients on buprenorphine require a surgical procedure, they need the analgesic efficacy of a full opioid agonist, but the opioids currently in use have a lower receptor binding affinity and cannot displace the partial agonist off the receptor, thereby limiting their effect," said Dr. Shaparin. "Sufentanil is unique in that it has a higher binding affinity to the mu-opioid receptor than buprenorphine, allowing DSUVIA to potentially provide these patients with more effective analgesia, " continued Dr. Shaparin. Dr. Shaparin previously served as a consultant for AcelRx and on advisory boards.

"The buprenorphine-treated patient has long posed a clinical challenge for anesthesiologists," said Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx. "Being able to provide these patients a perioperative analgesic option that may be more effective than traditional IV opioids could be yet another way for DSUVIA to advance acute pain management in medically supervised settings."