The Food and Drug Administration on Friday approved Dsuvia, a opioid tablet five to 10 times more powerful than fentanyl. The potential benefits of the drug to save military lives on the battlefield outweighed the risk that the new pills could be diverted to illicit use, the FDA said.
Dsuvia is a new formulation of sufentanil, an opioid that is currently administered intravenously. The drug was developed by AcelRx, a pharmaceutical company in Redwood City, CA, in conjunction with the Department of Defense. AcelRx’s stock surged 16% Friday on news of Dsuvia’s approval. Shares of AcelRx are up 134% so far in 2018, compared with a 1% gain in the S&P 500.
The FDA’s consideration of Dsuvia this year has faced controversy. Four U.S. senators have stated their opposition to its approval. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recently voted 10-3 last month in favor of approving the drug, although the committee’s chair Dr. Raeford Brown has been outspoken against the approval, noting that a separate FDA committee on drug safety was never convened to evaluate Dsuvia.
“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said in a statement. “I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”
“The military application for this new medicine was carefully considered in this case,” FDA Commissioner Scott Gottleib said in a statement, adding that the agency considers it a “high priority” to provide troops treatment for wounds when intravenous painkillers aren’t available. “There are very tight restrictions being placed on the distribution and use of this product,” Gottleib said.
Almost half of all overdose deaths in the United States are caused by Fentanyl, according to research released earlier this summer. According to the Washington Post, there are nearly 400 brand-name and generic opioid drugs on the market.