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"We need to address the question that I believe underlies the criticism raised in advance of this approval", Gottlieb wrote.

The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis. And it should only be administered by a health care provider using a single-dose applicator.

As the worst drug crisis in US history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals. And many of those will overdose and die.

The FDA is taking some precautions in the hopes that the drug will not be abused.

A panel of FDA advisers had earlier voted 10 to three 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.

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However, the FDA claims to have a strict control on the use of drugs inside a medical facility. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.

But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses.

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.

Hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal users over the past 15 years.

The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail.

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.


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