Approximately 72,000 people died in the U.S. last year as a result of an opioid overdose. While Americans and lawmakers both agree that more needs to be done to improve the opioid abuse epidemic, the FDA approved yet another potent opioid on Nov. 2.
FDA Commissioner Scott Gottlieb, MD, addressed some of the concerns over approval of the drug, Dsuvia.
The drug is restricted in use for settings that are medically supervised, including hospitals, surgical centers and emergency departments, and is administered by a healthcare professional. It’s also an under-the-tongue formulation that is taken in a single dose. Dsuvia is an oral formulation of sefentanil, an even more potent form of fentanyl, which was been blamed for many overdose-related deaths.
The drug also meets a need in the military, including treating soldiers on the battlefield, according to Gottlieb.
“There are very tight restrictions being placed on the distribution and use of this product,” Gottlieb said. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. 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 (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use.”
The FDA approved Dsuvia in a vote, despite objections from physicians and even the chair of the FDA advisory committee and the consumer advocacy group Public Citizen.
Over the past 20 years, opioid-related overdose deaths have increased more than five-fold, and Americans are increasingly concerned over the epidemic.
Public Citizen, a non-profit, progressive consumer rights advocacy group based in Washington, D.C., wrote to Gottlieb and other officials to oppose approval of the drug. Raeford Brown, MD, chair of the FDA advisory committee, also opposed the approval.
"I don't think this is going to help us in any way," he told NPR.
Among its restrictions, the drug cannot be used for more than 72 hours or in a home setting. It also won’t be available in retail pharmacies.