Powerful — and controversial — new opioid nears FDA approval - Entrepreneur Generations

Dr. Raeford Brown

A powerful — and controversial — new opioid may soon be approved by the U.S. Food and Drug Administration.

"The drug, Dsuvia, consists of a single-dose tablet of sufentanil, a synthetic opioid that is many times more potent than fentanyl and 500 times stronger than morphine," Emma Court reports for Marketwatch. "The tablet comes in a preloaded plastic applicator that is used to deposit the medication under a patient’s tongue."

The FDA's Anesthetic and Analgesic Drug Products Advisory Committee recently recommended the drug for U.S. approval with a 10-3 vote; the FDA is expected to make a final decision by Nov. 3, and though it usually follows such committee recommendations, it doesn't have to, Court reports.

Dsuvia comes in a single-dose package.
(Photo by AcelRx)

Dr. Raeford Brown, the committee's longtime chair and a professor of anesthesiology and pediatrics at the University of Kentucky, wrote an open letter to the FDA protesting Dsuvia, questioning the wisdom of adding another strong opioid to the market as the nation struggles with an opioid addiction epidemic. Brown noted that the drug's design makes it easier for someone who doesn't have a prescription to get ahold of it. The letter was co-signed by consumer advocacy group Public Citizen and Sen. Edward Markey, D-Mass.

"This drug offers no advance, in my mind, over previously available opioid formulations, but provides great risk of harm to patients and the general public health," Brown told Court.

Dsuvia's manufacturer, AcelRx Pharmaceuticals Inc., says the concerns are unfounded. Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx, said the design makes it easier for battlefield medics to use and that the dosage is too small for many drug addicts to get "excited about." The drug can also help elderly or obese patients, she said, since intravenous opioids can be difficult to administer for such patients and oral opioids take more time to begin working, Court reports. Palmer also said that the drug would only be distributed at hospitals and other medically supervised settings, and that it wouldn't be available at pharmacies.

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