FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

Grant Boone
November 7, 2018

The drug is 30-microgram in pill form. The medicine comes in a tablet that can dissolve under the tongue. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12. 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. "Addressing it is a public health priority for the FDA".

The consumer watchdog group Public Citizen has also come out strongly against approval.

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Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.

The medication should not be used for more than 72 hours at a time, according to the FDA. "That means it won't be available at retail pharmacies for patients to take home".

"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.

The United States continues to struggle with the opioid abuse epidemic. However, the approval indicates the opioid is to only be used in certified medically supervised health care settings, such as hospitals, surgical centers, and emergency departments. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

Scott Gottlieb was quick to defended the approval in a statement Friday: "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".

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