For treatment of moderate-to-severe acute pain in hospital, sublingual sufentanil (Dsuvia, AcelRx Pharmaceuticals) is well-tolerated, and most side effects are mild to moderate in severity, a new pooled safety analysis of clinical trial data shows.
"Pooling all of the data we were able to come up over 800 cases, which gives us a bigger group to do a safety analysis than individual smaller studies, and the findings are reassuring," first author James Miner, MD, chief of emergency medicine at Hennepin County Medical Center in Minneapolis, Minnesota, told Medscape Medical News.
The safety analysis was published online January 7 in Pain Management.
The study combined data from three phase 3 studies of sublingual sufentanil administered at 30-μg dose equivalents over a period of 72 hours or less for moderate-to-severe acute pain management used in the postoperative and emergency department settings. Of the 804 patients evaluated, 646 received active drug.
Overall, adverse events were experienced by 60.5% of patients in the sublingual sufentanil group and 61.4% in the placebo group. The most common treatment-related adverse events with sublingual sufentanil were nausea (28.5%), vomiting (6.5%), and headache (5.0%).
Nausea was the main side effect, "which is to be expected with opioids, but the rates were actually a little lower than I would have guessed," said Miner.
The potential for cognitive impairment with sublingual sufentanil was assessed in the open-label SAP302 study of patients treated in the emergency department, which Miner led.
A total of 75 patients who received 30 μg sufentanil were evaluated pre-dose and 1-hour post-dose for cognitive impairment using a validated six-item screening tool. In 97.3% of the patients, the score stayed the same or improved following the 30-μg dose, the authors report.
Miner said he can envision using the drug in a patient who presents to the emergency department in severe pain before they have an IV in place, or in a patient in severe enough pain to require an IV opioid but who would otherwise not need an IV. "For example, someone with just had a broken ankle or broken leg, where we wouldn't be doing an IV otherwise," he said.
Sublingual sufentanil was approved by the US Food and Drug Administration (FDA) in November for use in adults in a certified medically supervised healthcare setting, such as hospitals and surgical centers, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
But controversy surrounded the 10-3 vote in favor of Dsuvia by the Anesthetic and Analgesic Drug Products Advisory Committee and the FDA's subsequent approval. Public Citizen, a nonprofit consumer advocacy organization, and Raeford Brown, MD, head of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee, claimed the panel made the wrong call and that the vote to approve the drug was rigged.
Howard Mell, MD, spokesperson for the American College of Emergency Physicians (ACEP), is also no fan of Dsuvia.
The letter ACEP wrote to the FDA on sublingual sufentanil was "quite clear in saying we don't need this medicine, there is no indication for this product, there is no failure of the currently available opioid modalities, and so this is really a solution in search of a problem," he noted in an interview with Medscape Medical News.
"And this drug is rife for diversion and abuse," said Mell. "That might be acceptable if we really needed it, if there was some big problem or pharmacokinetic failure it is solving and there isn't."
The sublingual sufentanil studies were funded by AcelRx Pharmaceuticals and funded in part by the Clinical and Rehabilitative Medicine Research Program of the US Army Medical Research and Materiel Command. Miner is a consultant for AcelRx and has received research funding from the company. Mell has reported no relevant disclosures related to this research.
Pain Manag. Published online January 7, 2019. Abstract
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Cite this: Sublingual Sufentanil: A Solution in Search of a Problem? - Medscape - Jan 14, 2019.