In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.
This makes Dsuvia 1000 times stronger than morphine.
Dsuvia comes as a tablet in an applicator that health care providers administer under the tongue.
The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis. The tiny pill - just three millimeters in diameter - is likely to worsen the nation's drug crisis, according to critics and the head of the FDA's advisory committee on painkillers. "It can't be dispensed to patients for home use and should not be used for more than 72 hours". Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. There are also "very tight restrictions being placed on the distribution and use of this product", Gottlieb says. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record past year with 72,000 deaths - about 200 per day. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
More: Drugs kill more Americans than guns, cars and AIDS. "The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield". A spokeswoman said the company is not providing information on expected sales.
In a statement, FDA Commissioner Scott Gottlieb M.D. explained that the drug could be of good use in cases where the patient may not be able to swallow properly, and how the Department of Defense worked closely with the sponsor in the development of the drug, particularly because of its need to treat soldiers in the battlefield. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.