MA pols wary of new Rx opioid

Henrietta Strickland
November 7, 2018

In a statement he noted that "an opioid that is 1,000 times more powerful than morphine is 1,000 times more likely to be abused, and 1,000 times more likely to kill". The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. "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". Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States.

"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.

But the criticism was quick. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Diversion, of course, is the term used to describe how drugs end up in the hands of someone other than the intended patient.

He also called the drug "a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".

The same drug, with the chemical name sufentanil, is already available as an IV medication. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

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.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.

Other reports by Click Lancashire

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