Powerful Opioid Pill Gets FDA Approval

WASHINGTON (CN) — Announcing the approval of a tablet alternative to a powerful opioid normally delivered intravenously, the commissioner of the Food and Drug Administration promised Friday that the drug Dsuvia will be very tightly regulated.

AcelRx Pharmaceuticals is the maker of the sufentanil medication Dsuvia, which the U.S. Food and Drug Administration approved on Nov. 2. 2018, as an alternative to IV painkillers used in hospitals. (Craig Sherod Photography via AcelRx Pharmaceuticals)

“We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis,” FDA Commissioner Scott Gottlieb said in a statement. “We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy to accompany this drug.”

Though critics point to the drug’s potential for abuse, the FDA says the market had a need for “an oral formulation of sufentanil – a more potent form of fentanyl that’s been approved for intravenous and epidural use in the U.S. since 1984.”

“Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible,” FDA Commissioner Scott Gottlieb said in a statement. “This includes potential uses on the battlefield. For this reason, the Department of Defense worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee.”

Gottlieb said that the FDA has prioritized making treatments available to soldiers on the battlefield, “including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds.”

Among various limitations on the product’s use is that retail pharmacies cannot carry it. Use of the drug will also be reserved only for patients who cannot tolerate alternative pain treatment options.

“These measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse of Dsuvia, as well reduce the potential for diversion,” Gottlieb said.

In addition to the prohibition against home-use distribution, the FDA said the drug should only be administered by a health care provider using a single-dose applicator, and should not be used for more than 72 hours.

Dsuvia, which is made by AcelRx Pharmaceuticals, is said to cause the possible side effects of nausea, headache, vomiting, dizziness and hypotension.

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