TRENTON, N.J. — U.S. regulators 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 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. 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., predicts that the pill will be abused inside and outside medical settings and cause overdose deaths.

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

– Associated Press


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