Published: Thu, November 08, 2018
Health Care | By Terrence Lopez

FDA approves a powerful new opioid, rejecting criticism from advisers

FDA approves a powerful new opioid, rejecting criticism from advisers

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

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 drug is called Dsuvia, and FDA commissioner Scott Gottlieb, MD, addressed the timing in a statement released late last week. "The crisis of opioid addiction is an issue of great concern for our nation", he said. 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.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?"

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. 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 a year ago with 72,000 deaths - about 200 per day.

The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month.

Gottlieb is committed to bringing a plan the FDA's Opioid Policy Steering Committee and maybe even the Congress.

The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms.

In a statement, he said, "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain".

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical.

More: Drugs kill more Americans than guns, cars and AIDS.

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds", he wrote. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

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