Opioid 500 times stronger than morphine gets OK

Opioid 500 times stronger than morphine gets OK

Opioid 500 times stronger than morphine gets OK

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. "The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid", a statement from the public advocacy group Public Citizen said in response to the approval.

But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia.

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

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement.

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. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.

Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.

The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month.

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. "The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield". Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously. A spokeswoman said the company is not providing information on expected sales. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.

Related news



[an error occurred while processing the directive]