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 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.
According to Gottlieb, there are very tight limitations for the use of the drug.
Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death.
In approving the drug, the agency skirted its normal vetting process, these critics say. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments. 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.
In a statement issued Friday, the group contended that, "if approved, Dsuvia will be abused and start killing people as soon as it hits the market".
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. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.
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Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer. Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.
"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. A spokeswoman said the company is not providing information on expected sales.
In one study, the pill provided about the same pain relief to patients as IV morphine.