FDA Approves Painkiller Dsuvia Amid Criticism

FDA approves powerful opioid despite fears of more overdose deaths

FDA approves new opioid

It is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, he warned.

Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form.

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 medication, which comes in a single-use package, also should not be used for more than 72 hours.

Can the drug be prevented from being abused and misused? Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

The company producing Dsuvia, AcelRx, argued it would be an "important non-invasive, rapidly acting alternative to IV opioids". According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said. "This drug just will work a lot more than morphine - it's 1,000 times stronger", she says.

Gottlieb is committed to bringing a plan the FDA's Opioid Policy Steering Committee and maybe even the Congress.

"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 statement noted the benefit the drug could have for soldiers injured on the battlefield.

The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings.

"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", Gottlieb wrote.

"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", he said.

"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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