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.

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.

Dr. Brown also questioned whether the F.D.A. would succeed in enforcing regulations once dangerous drugs hit the market.

“It is my observation that once the F.D.A. approves an opioid compound,” he wrote, “there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population.”

The divisions over the new drug’s approval comes after opioid overdose deaths surged to more than 40,000 last year, including more than 30,000 from fentanyl and other synthetic opioids.

https://www.nytimes.com/2018/11/02/h...fda-opoid.html