[ad_1]
TRENTON, N.J. (AP) – US regulators approved Friday a fast-acting, super-potent opioid tablet, 10 times more potent than fentanyl, and 1000 times more potent than morphine.
The drug Dsuvia has been developed as an alternative to intravenous badgesics used in hospitals.
The decision of the Food and Drug Administration has been taken into account by critics fearing that the pill is misused. In a lengthy statement, FDA Commissioner Scott Gottlieb said his distribution would be subject to "very strict restrictions" and that it was intended only for supervised institutions, such as hospitals.
The tiny pill has been developed as an option for patients who have problems using intravenous solutions, including soldiers on the battlefield. The AcelRx Pharmaceuticals pill contains the same decades-old badgesic often given intravenously or by injection to operated patients and working women.
Gottlieb pointed out that the pill was a top priority for the Ministry of Defense, which helped fund the tests, as it sought a way to quickly relieve the pain of wounded soldiers. The tablet, placed under the tongue with a dispenser, reduces the pain in 15 to 30 minutes.
A panel of FDA advisers had previously voted 10-3 in favor of the pill called Dsuvia (duh-SOO -vee-uh). But in a rare response, the panel chairman joined the critics in urging the FDA to reject it. The President, Dr. Raeford E. Brown Jr., who was unable to attend the meeting and did not vote, predicted that the pill would be abused inside and outside the medical community and would cause death by overdose.
The tablets contain sufentanil, a chemical cousin of fentanyl, an opioid.
Gottlieb said the drug will have a warning and will not be available in pharmacies for patients to take home. Acknowledging the critics, he asked the FDA staff to evaluate "a new framework" for the approval of new opioid drugs, which will clearly explain how the agency considers the benefits and risks.
"We will not stall on what I believe to be the real source of underlying discontent among critics of this approval – the question of whether America needs another opioid powerful while she is in a crisis of dependency, "writes Gottlieb.
Sidney Wolfe of the Health Research Group Public Citizen, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency had missed a great opportunity by approving the pill.
"It's a huge mistake," Wolfe said. "This drug is doomed, it's dangerous and it's going to kill people."
The company based in Redwood City, California, expects the pill to be available early next year at a price of $ 50 to $ 60 a pill.
In one study, the pill provided about the same pain relief as intravenous morphine. Common side effects of Dsuvia include nausea, vomiting, constipation and a decrease in oxygen levels in the blood. These occurred a little more often with the pill than for the participants in the study receiving morphine.
Source link
