FDA Goes Ahead With Approval of Sufentanil Despite Controversy

Megan Brooks


November 02, 2018

The US Food and Drug Administration (FDA) has approved sufentanil sublingual tablets (Dsuvia, AcelRx Pharmaceuticals) for management of severe acute pain in adults in certified, medically supervised healthcare settings.

The Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 in favor of sufentanil sublingual tablets last month, as reported by Medscape Medical News.

However, in a release, Public Citizen, a nonprofit consumer advocacy organization, and Raeford Brown, MD, head of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee, claim the panel made the wrong call and that the vote to approve the drug was rigged.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly," said Sidney Wolfe, MD, founder and senior adviser of Public Citizen's Health Research Group.

"It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die. It is likely, if not certain, that Dsuvia will be banned after 'enough' such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms," Wolfe added.

In the same release, Brown stated he was "very disappointed with the decision of the agency to approve Dsuvia.

"This action is inconsistent with the charter of the agency. As I discussed with representatives of the agency today, the lack of efficacy data and the sponsor's inadequate response to safety concerns have not been addressed since the FDA's complete response letter was sent in 2017.

"Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect. I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic," said Brown.

More Potent Than Fentanyl

Sufentanil is a synthetic opioid analgesic that is five to 10 times more potent than its analogue, fentanyl (multiple brands) and 1000 times more potent than morphine. It's currently marketed for intravenous and epidural anesthesia and analgesia.

The sublingual formulation of sufentanil is designed for rapid pain relief. Its onset of action is as little as 15 minutes, and it provides about 3 hours of analgesia.

Dsuvia contains 30 μg sufentanil. It comes in single-dose, prefilled applicator for sublingual administration by healthcare professionals in hospitals, surgical centers, and emergency departments.

"The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion," the company said in a news release.

One phase 3 placebo-controlled trial presented by the company at the FDA committee meeting included 161 adult patients who experienced acute pain following abdominal surgery. Patients reported pain on an 11-point numerical rating scale. The study showed a statistically significant difference in pain intensity at 12 hours between treatment groups (mean difference with placebo, 12.7; 95% confidence interval, 7.2 - 18.2; P < .001).

Efficacy was supported by results of secondary outcomes, including time to first use of rescue medication and amount of rescue medication used during the first 12 hours.

Another study in patients who underwent bunionectomy also showed that the intervention significantly reduced pain compared to placebo.

Adverse events were generally consistent with those associated with opioids in the postsurgical setting. The most common were nausea, headache, and vomiting, with nausea and vomiting occurring more frequently in the group taking sufentanil than in the group taking placebo.

"Managing acute pain is critical to a patient's recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients," David Leiman, MD, clinical assistant professor of surgery, University of Texas Health Science Center at Houston, said in a news release from the manufacturer.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, Dsuvia represents an important alternative for healthcare providers to offer patients for acute pain management," said Leiman.

The company expects to launch Dsuvia in the first quarter of 2019.

It will not be available in retail pharmacies or for outpatient use but will only be distributed to healthcare settings certified in the Dsuvia risk evaluation and mitigation strategy program following demonstration by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of its use.

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