Thursday, 15 November, 2018

FDA approves powerful opioid despite fears of more overdose deaths

FDA approves new opioid FDA approves new opioid
Johnnie Parks | 07 November, 2018, 23:30

The opioid medication is a form of sufentanil, considered 5 to 10 times more powerful than fentanyl and 1000 times more potent than morphine.

News outlets have decried the approval and emphasized sufentanil's effects as "500 times more powerful than morphine;" however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.

"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.

Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is restricted to use in certified, medically supervised health care settings - such as hospitals, surgical centers and emergency departments - for administration by a health care professional". 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 FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb said in an agency news release. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need.

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

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

"DSUVIA will not be available in retail pharmacies or for outpatient use".

The drug is intended for use within health-care settings and perhaps on the battlefield. The opioid in question is a highly potent, and unsafe drug that has more risks than benefits in health-care.

An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis". Company executives said they expect to launch Dsuvia in the first quarter of 2019.

As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said.

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