Benzinga | Aug 19, 2020 08:40AM EDT

AcelRx Pharmaceuticals Highlights Publication Of Clinical Data On Reduced Opioid Use And Reduced Time In Postanesthesia Care Unit (PACU) Following Preoperative Administration Of DSUVIA

REDWOOD CITY, Calif., Aug. 19, 2020 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management.

"The observations in this study strongly support utilizing DSUVIA over intravenous bolus opioids, consistent with opioid stewardship programs and enhanced recovery after surgery protocols, which focus on minimizing opioid dosing in multimodal analgesic protocols," said Dr. Christian Tvetenstrand, Chairman of Surgery and Director of Trauma, United Health Services Wilson Medical Center, New York. "I strongly believe this data on preoperative DSUVIA administration will result in a paradigm shift in pain management protocols across all ambulatory surgeries, as we have already seen significant cost savings due to less medical intervention and improved patient recovery."

The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study, with the following key findings:

* Discharge from the PACU occurred 34% faster than controls (36.3 min vs. 54.9 min; p < 0.001).

* Significantly fewer DSUVIA treated patients required intraoperative IV opioid following preoperative dosing with DSUVIA compared with the control group (61.7% vs. 97.5%, respectively; p < 0.001).

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* DSUVIA patients received a total preoperative and intraoperative mean opioid dose of 10.9 milligram morphine equivalents (MME), while the mean dose for controls was 20.0 mg MME (p < 0.001).

* Fewer DSUVIA-treated patients required any postoperative opioid (10.5% vs. 63.0%; p < 0.001) with overall opioid utilization being reduced by over 50% with DSUVIA use throughout the perioperative setting (11.8 MME vs. 24.6 MME; p < 0.001).

* Significantly fewer patients in the DSUVIA group received adrenergic agonists and IV acetaminophen.

The study concluded that the preoperative administration of DSUVIA results in significant reductions in opioid use during outpatient surgery and facilitates shorter PACU stays. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients.

"The results of this study build on an ever-increasing clinical dataset demonstrating the benefits of sublingual sufentanil. The standard of care for perioperative opioid administration has not been disrupted for over 100 years. We should no longer accept the rapid plasma fluctuations of IV bolus opioid administration as the status quo, as it impacts the patient's hemodynamic status and requires repeated redosing which ultimately results in higher overall opioid exposure," commented Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "DSUVIA for the first time offers a unique pharmacokinetic profile for an opioid in the perioperative setting and other medically supervised settings. We expect this study to be one of several upcoming datasets to support the broad acceptance of DSUVIA as an alternative to IV opioids."