"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.
The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.
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.
Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form.
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. 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.More news: Rockstar Working on Fix for Red Dead Redemption 2 Camp Glitch
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To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia.
Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.
According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States.
Health experts said the pill isn't needed and will only worsen the opioid epidemic. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo. The objective, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.