But U.S. Sen. Edward J. Markey, D-Mass., sharply criticized that vote, saying Dsuvia is an opioid painkiller up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine. The drug is 30-microgram in pill form. The tiny pill comes packaged in a syringe-like applicator and would be used under the tongue for quick absorption. Finally, the open-label SAP303 study in patients with moderate to severe acute pain after surgery found that safety and efficacy of the drug were similar among patients regardless of their age, renal function, or liver function.
The FDA says that controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves.
"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 related to battlefield wounds", he wrote. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. But the committee's chair took the highly unusual move of voicing his opposition at that time.
"I am very disappointed with the decision of the agency to approve Dsuvia".
"This action is inconsistent with the charter of the agency", wrote Brown, who is also a professor of anesthesiology and pediatrics at the University of Kentucky's medical school. However, despite the warnings, the opioid has been approved by the FDA for use in health-care.
The Food and Drug Administration approved a drug called Dsuvia Friday.
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Dsuvia is 10 times more powerful than fentanyl. The medication, which comes in a single-use package, also should not be used for more than 72 hours.
According to the FDA, Dsuvia will not be available in retail pharmacies or for outpatient use. It'll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain.
The United States continues to struggle with the opioid abuse epidemic.
As the worst drug crisis in USA history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added.
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.
"The problem is we have this legacy of a lot of addiction associated with past activities, and we are still seeing too much utilization that is fueling too much new addiction", he said.