Despite warnings of likely abuse F.D.A. approves powerful new opioid

Opioid and substance abuse are challenges that need to be combated on an urgent basis. The Food and Drug Administration (F.D.A.) approved a new form of an extremely potent opioid to manage acute pain in adults. This decision comes weeks after the chairman of the advisory committee that reviewed it, asked the agency to reject it on the grounds that it could be abused.

Dr. Scott Gottlieb, the F.D.A. commissioner, released a lengthy statement defending the agency’s decision. He stressed the point that Dsuvia is delivered through a “pre-filled, single-dose applicator,” and its permitted use will be in hospitals, surgical centers and other medically supervised settings. It is quite suited only for certain circumstances, especially for soldiers wounded on the battlefield who lack access to intravenous painkillers.

Dr. Gottlieb wrote that Dsuvia will not be dispensed to patients for home use or available at retail pharmacies. It should only be administered by healthcare providers with the single-dose applicators. It will mostly hit the market early next year. Last year the F.D.A told the make of Opana ER, another super-potent opioid, to take it off the market due to concerns about abuse.