TRENTON, N.J. (AP) – US regulators approved a fast-acting, high-potency opioid tablet on Friday that is ten times more potent than fentanyl and 1,000 times more potent than morphine.
The drug Dsuvia was developed as an alternative to IV painkillers used in hospitals.
The decision of the Food and Drug Administration met with objections from critics who fear the pill will be abused. In a detailed statement, FDA Commissioner Scott Gottlieb said there would be "very tight restrictions" on distribution, and it was only for supervised facilities such as hospitals.
The tiny pill was developed as an option for patients who have difficulty in using infectious diseases, including soldiers on the battlefield. The pill from AcelRx Pharmaceuticals contains the same decades-old analgesic that is often given to surgical patients and women at work in the form of an intravenous injection or injection.
Gottlieb pointed out that the pill was a high priority for the Department of Defense, which supported the test funding, as it sought a way to allow injured soldiers a quick pain relief. The tablet, which is placed under the tongue with a donor, begins to reduce the pain after 15 to 30 minutes.
A panel of FDA advisors had previously chosen 10-3 for the pill called Dsuvia (duh-SOO & # 39; -vee-uh). In a rare response, the jury chairman challenged the FDA's criticism of pushing the FDA to reject it. The Chairman, Dr. Raeford E. Brown, Jr., who was unable to attend the meeting and has not cast a vote, predicts that the pill will be abused inside and outside medical facilities and lead to overdose deaths.
The pills contain sufentanil, a chemical cousin of the opioid fentanyl.
Gottlieb said the drug will carry a box of warnings and will not be available in pharmacies so patients can take it home. In recognition of the criticism, he said he had asked the FDA staff to evaluate a "new framework" for the approval of new opioid medications, which clearly sets out how the agency rates benefits and risks.
"We will not dodge what I think is the real cause of dissatisfaction among the critics of this approval – the question of whether or not America needs another strong opioid in a serious addiction crisis," wrote Gottlieb.
Sidney Wolfe of the Public Citizens Health Research Group, a consumer group, cited Gottlieb's testimony as "empty rhetoric" and said the agency had missed a great opportunity when she approved the pill.
"It's a big mistake," Wolfe said. "This drug is doomed to fail, it is dangerous and will kill people."
Based in Redwood City, Calif., The company expects the pill to be available early next year at a cost of $ 50 to $ 60 per pill.
In one study, the pill provided patients with approximately the same pain relief as IV morphine. Common side effects with Dsuvia were nausea, vomiting, constipation, and decreased blood oxygen levels. These occurred a little more frequently in the pill than in study participants who were given morphine.