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AcelRx Pharmaceuticals Announces Publication of Clinical Data on Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit (PACU) Following Preoperative Administration of DSUVIA®
"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.
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).
- 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.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO™ in
This press release contains forward-looking statements, including, but not limited to, statements related to our expectations for upcoming datasets to support the broad acceptance of DSUVIA as an alternative to IV opioids. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including the risk that upcoming datasets are not published. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
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