FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill".

Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is restricted to use in certified, medically supervised health care settings - such as hospitals, surgical centers and emergency departments - for administration by a health care professional".

The FDA has approved this new drug in the midst of a severe opioid epidemic in the country. 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.

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.

In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. There are also "very tight restrictions being placed on the distribution and use of this product", Gottlieb says.


The company producing Dsuvia, AcelRx, argued it would be an "important non-invasive, rapidly acting alternative to IV opioids". The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies.

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

The Food and Drug Administration is facing criticism over the approval of a drug called Dsuvia.

"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", he said.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

"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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