FDA Approves Controversial New Opioid

08 November, 2018, 08:37 | Author: Denise Dawson
  • FDA approves new opioid

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock. And it should only be administered by a health care provider using a single-dose applicator. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need.

According to Gottlieb, there are very tight limitations for the use of the drug.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?" The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics.

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.

More: Drugs kill more Americans than guns, cars and AIDS.

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The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

A panel of FDA advisers had earlier voted 10 to three in favor of the pill called Dsuvia, but in a rare response, the panel's chairman joined critics in urging the FDA to reject it. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. It is expected to be available in the first quarter of next year.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

In a statement, he said, "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain".

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

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