Amid deepening addiction crisis, FDA approves new form of powerful opioid

FDA approves new opioid

FDA approves new opioid

Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia.

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.

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.

According to Gottlieb, there are very tight limitations for the use of the drug.

Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic-which killed a record 49,000 users in 2017, according to preliminary data-with the needs of people who need strong pain relief.

But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses. It'll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. It's an alternative to IV painkillers used in hospitals.

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Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.

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. And many of those will overdose and die.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. A spokeswoman said the company is not providing information on expected sales.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

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