FDA approves super-potent opioid pill despite fears of abuse, overdose deaths

This undated image shows the dispenser and a tablet for the medication Dsuvia. U.S. regulators announced the approval of the fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals Friday, Nov. 2. 2018 | Photo courtesy of Craig Sherod Photography/AcelRx Pharmaceuticals via The Associated Press, St. George News

TRENTON, N.J. (AP) — U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. In a lengthy statement, FDA Commissioner Scott Gottlieb said there will be “very tight restrictions” placed on its distribution and that it is intended only for supervised settings like hospitals.

The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor.

Gottlieb noted the pill was a high priority for the Department of Defense, which helped fund testing, because it wanted a way to provide fast pain relief to injured soldiers. The tablet, placed under the tongue with a dispenser, starts reducing pain in 15 to 30 minutes.

A panel of FDA advisers had earlier voted 10-3 in favor of the pill called Dsuvia (duh-SOO’-vee-uh). But in a rare response, the panel’s chairman joined critics in urging the FDA to reject it. The chairman, Dr. Raeford E. Brown Jr., who couldn’t attend the meeting and didn’t cast a vote, predicts that the pill will be abused inside and outside medical settings and cause overdose deaths.

This undated image shows the dispenser and a tablet for the medication Dsuvia. U.S. regulators announced the approval of the fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals Friday, Nov. 2. 2018 | Photo courtesy of Craig Sherod Photography/AcelRx Pharmaceuticals via The Associated Press, St. George News

The pills contain sufentanil, a chemical cousin of the opioid fentanyl.

Gottlieb said the drug will carry a boxed warning and won’t be available at drugstores for patients to take home. Acknowledging the criticism, he said he’s asked FDA staff to “evaluate a new framework” for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.

“We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval — the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,” Gottlieb’s wrote.

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.

“It’s a huge mistake,” Wolfe said. “This drug is doomed. It’s dangerous, and it will kill people.”

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.

In one study, the pill provided about the same pain relief to patients as IV morphine. Common side effects with Dsuvia included nausea, vomiting, constipation and decreased blood oxygen levels. Those occurred slightly more often with the pill than for study participants given morphine.

Written by LINDA A. JOHNSON, Associated Press medical writer. Carla K. Johnson contributed from Seattle.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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2 Comments

  • DRT November 5, 2018 at 3:28 pm

    “FDA Commissioner Scott Gottlieb said there will be “very tight restrictions” placed on its distribution and that it is intended only for supervised settings like hospitals.

    The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.”

    So this means that the battlefield is going to be in supervised settings like hospitals?
    I’ve really no opinion on the drug itself, but I just love to read these contradictory statements.

  • Larry November 6, 2018 at 7:25 am

    The Battlefield? So the product derived from the poppies we are defending in Afghanistan will be packaged and sent back in a very expensive pill dispenser. Isn’t Profit wonderful!!! (hey at least the War in Afghanistan is starting to make sense….that is, if you are on drugs!) PEZ anyone?

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