FDA attacked for OK'ing a painkiller stronger than morphine

FDA approves new opioid

On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved a new sublingual formulation and delivery system of the synthetic opioid sufentanil for managing moderate-to-severe acute pain in adults who are in medically supervised settings, such as hospitals, surgical centers, and emergency departments.

Dsuvia is 10 times more powerful than fentanyl.

Dsuvia is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a health care professional only in certified medically supervised settings. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", he said.

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Following the approval of Dsuvia, Gottlieb acknowledged that opioids are a unique class of medications.

Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.

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

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

The drug, Dsuvia, is a quick-dissolve tablet designed as an alternative to the rapid-fire infusion of pain meds available via IV at a hospital. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

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