A recent postoperative pain study sponsored by AcelRx Pharmaceuticals has demonstrated the safety and efficacy of sublingual sufentanil for controlling moderate to severe acute postoperative pain. AcelRx has an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to prove that sublingual sufentanil mini tablets are safe and efficacious in the treatment of moderate to severe acute postoperative pain. The sponsor approached Sheridan Clinical Research in April, 2016 about participating in this multicenter, randomized study of its 30-mcg sublingual sufentanil tablet, which must be administered by a healthcare professional. Sheridan anesthesiologist Juan Restrepo, MD, who had participated previously in a study of patient-controlled, 15-mcg sublingual sufentanil, was the Principal Investigator for the location research conducted at Boca Raton Regional Hospital. For this study, Dr. Restrepo followed a randomized group of patients who had a procedure with general or spinal anesthesia and who needed to remain at the hospital for at least 12 hours afterward.
Sublingual sufentanil adheres to the sublingual mucosa within seconds of administration. Due to its very small size, it causes minimal taste and saliva response, minimizing the amount of swallowed drug. The 30-mcg sublingual sufentanil tablet is in Phase III development. Per an Anesthesiology News article, the tablet is being developed in collaboration with the Department of Defense, which hopes to use it to treat moderate to severe acute pain in settings such as battlefield trauma, emergency medicine and ambulatory surgery.
Pamela Palmer, MD, PhD, chief medical officer and co-founder of AcelRx Pharmaceuticals, said in the article that results from the multicenter study suggest that 30-mg tablets are “efficacious and well tolerated across a variety of ambulatory surgery procedures for the management of moderate to severe acute postoperative pain.” She continued, “Patient comfort and satisfaction postoperatively and time to discharge are critical end points, and sublingual sufentanil appears to address both of these. Sufentanil’s prompt absorption into the central nervous system and lack of active metabolites scientifically support such desirable outcomes.”
Juan Restrepo, MD