AcelRx announced results from a pooled analysis of clinical studies assessing the safety of sufentanil sublingual tablet (Dsuvia) for the short-term management of moderate-to-severe acute pain in medically supervised settings. The findings have been published in Pain Management.

The pooled analysis (N=804) evaluated clinical studies of sufentanil sublingual tablet (SST) at 30mcg dose equivalents over ≤72 hours for moderate-to-severe acute pain management in both postoperative and emergency room patients; a subset of postoperative patients from Phase 2/3 SST 15mcg studies who received 2 doses within 20-25 minutes of each other (30mcg dose-equivalent) were also included. 

Results showed that adverse events (AEs) were observed in 60.5% of patients in the SST group compared with 61.4% in the placebo group; 43.8% of patients who received SST experienced treatment-related AEs vs 33.5% of placebo patients (10.3% difference; 95% CI: 2.0–18.6). Nausea (28.5%), vomiting (6.5%), and headache (5.0%) were the most common treatment-related AEs reported. In a study involving 75 emergency room patients administered SST 30mcg, no evidence of cognitive impairment was observed following treatment. “Findings from the pooled analysis support that SST is well-tolerated, with most AEs considered mild or moderate in severity, for the treatment of moderate-to-severe acute pain in medically supervised settings,” the authors reported.

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The study also assessed the morphine equivalence of SST based on data from an active-comparator study (N=357) evaluating 2 patient-controlled analgesic (PCA) systems. The authors noted that “Within the first 5 hours after initiation of the first dose of treatment with SST 15mcg PCA or IV morphine PCA (the time during which active morphine metabolites will not yet have accumulated and exerted analgesic effects), SST 15mcg was calculated to be equal to approximately 2.5mg IV morphine based on drug utilization in each treatment group over this 5-hour period (or 5mg IV morphine for 30mcg SST).”

Dsuvia was approved by the Food and Drug Administration (FDA) in November 2018 for use in adults in a certified medically supervised healthcare setting, 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.

“With the increasing demographic of patients with obesity or who are elderly, multiple IV attempts [for opioid analgesia] are often required, which increases discomfort, time and costs,” said Dr Pamela Palmer, CMO of AcelRx, discussing the differences between SST and morphine. “So there are multiple advantages to Dsuvia in medically supervised settings in the civilian environment in addition to the advantages in the battlefield.” SST development was partially supported by the Department of Defense to create a new treatment for battlefield analgesia.

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