Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that's said to be 10 times more powerful than fentanyl.
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. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record past year with 72,000 deaths - about 200 per day. "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits".
Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form.
The medication won't be available at pharmacies and shouldn't be used for more than 72 hours.
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To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia. "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", Dr. Gottlieb said. "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". For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine.
In one study, the pill provided about the same pain relief to patients as IV morphine. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program".
Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.
The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.