Published: Wed, November 07, 2018
Medicine | By Brett Sutton

FDA approves highly effective new opioid regardless of ongoing epidemic

FDA approves highly effective new opioid regardless of ongoing epidemic

"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.

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.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill".

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. In a statement, FDA Commissioner Scott Gottlieb said that "very tight restrictions" will be placed on the drug.

The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency.

Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic-which killed a record 49,000 users in 2017, according to preliminary data-with the needs of people who need strong pain relief.

The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.

The drug, Dsuvia, is a quick-dissolve tablet designed as an alternative to the rapid-fire infusion of pain meds available via IV at a hospital.

Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

The FDA is taking some precautions in the hopes that the drug will not be abused. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

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