MA pols wary of new Rx opioid

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"This drug just will work a lot more than morphine - it's 1,000 times stronger", she says.

"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.

FDA Commissioner Scott Gottlieb, M.D., released a lengthy statement regarding the drug's approval, reading, in part: "the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible". Critics point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone.

To that, however, anesthesiologist Dr. Pamela Palmer-who is also the co-founder of AcelRx-argues that "diversion" of Dsuvia is extremely low.

The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis.

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One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement.

The drug is for very restricted use in operating rooms or on the battlefield.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

The new, single-dose tablet version of the pain killer, mean to be taken under the tongue, can only be given in hospitals and is meant for those who can't take an IV. The drug's manufacturer, AcelRx, said the drug will be marketed with the name Dsuvia and cost between $50 and $60 per dose. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years. Company executives said they expect to launch Dsuvia in the first quarter of 2019. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo. "The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield".

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