On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved a new sublingual formulation and delivery system of the synthetic opioid sufentanil for managing moderate-to-severe acute pain in adults who are in medically supervised settings, such as hospitals, surgical centers, and emergency departments.
The FDAannounced 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. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market.
According to Gottlieb, there are very tight limitations for the use of the drug. The medication, which comes in a single-use package, also should not be used for more than 72 hours. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. 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.
Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.
The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail.
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.
An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical.
The drug, called Dsuvia, was approved Friday as a fast-acting alternative to intravenous painkillers.
The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.
And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.
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Don't let them run the okey-doke on you", Obama said Sunday during a campaign stop in Gary, Ind., for Democratic incumbent Sen. In 2010, the Tea Party swing of 63 seats gave the Republicans the House: Barack Obama would never get control of it back.
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