FDA approves opioid 10 times stronger than fentanyl

WASHINGTON — The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused.

The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years.

Although the F.D.A. advisory committee charged with evaluating the new formulation ultimately recommended in a 10-3 vote last month that the agency approve it, the panel’s chairman, Dr. Raeford Brown, wrote a letter to top F.D.A. officials afterward expressing deep concern.

In the letter, which he wrote with leaders of the consumer advocacy group Public Citizen, Dr. Brown, an anesthesiology professor at the University of Kentucky, described Dsuvia, made by AcelRx Pharmaceuticals, as “an extremely divertible drug,” adding, “I predict that we will encounter diversion, abuse and death within the early months of its availability on the market.

After the final approval on Friday, Dr. Scott Gottlieb, the F.D.A. commissioner, released a lengthy statement defending the agency’s decision. He emphasized that Dsuvia is delivered through a “pre-filled, single-dose applicator,” and said that its only permitted use will be in hospitals, surgical centers and other medically supervised settings. It is ideally suited for certain special circumstances, he said, particularly for soldiers wounded on the battlefield who might not have access to intravenous painkillers.

Dr. Gottlieb wrote that Dsuvia will not be dispensed to patients for home use or available at retail pharmacies, and that it should only be administered by health care providers with the single-dose applicators. It will likely hit the market early next year.

“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,” he wrote.

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