Published: Thu, November 08, 2018
Medicine | By Ray Hunter

FDA approves opioid painkiller 1000 times stronger than morphine

FDA approves opioid painkiller 1000 times stronger than morphine

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public. It is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, he warned.

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

An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month. More: The opioid crisis hits home. The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. 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. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.

"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", said Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx.

"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval-the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb's wrote. 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 medication won't be available at pharmacies and shouldn't be used for more than 72 hours. 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.

In approving the drug, the agency skirted its normal vetting process, these critics say.

The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. It is expected to be available in the first quarter of next year.

"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.

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