FDA Approves Painkiller Dsuvia Amid Criticism

FDA Approves Painkiller Dsuvia Amid Criticism

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". 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.

"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 said in his written statement. Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show. But FDA Commissioned Scott Gottlieb stated he would seek more authority for the agency to deny future applications for new drug opiod approvals. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

A month prior to the FDA's approval, critics urged the agency not to approve the drug because of its potential to be abused and misused, especially amid the ongoing opioid crisis.

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

Accordingly, then, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted in favor, 10 to 3, of approval of this medication. 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.

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There's more on pain control at the American Society of Anesthesiologists.

The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

US regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

Including brand name and generic drugs, there are almost 400 opioids now on the market. "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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