FDA approves opioid painkiller 1000 times stronger than morphine

FDA approves powerful opioid despite fears of more overdose deaths

Democratic Senator Ed Markey of MA urged the FDA not to approve the painkiller 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."To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia.Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said".

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says.

According to Gottlieb, there are very tight limitations for the use of the drug. "It can't be dispensed to patients for home use and should not be used for more than 72 hours".

In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. It's an alternative to IV painkillers used in hospitals. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said.

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. "That means it won't be available at retail pharmacies for patients to take home".

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

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. Company executives said they expect to launch Dsuvia in the first quarter of 2019. And many of those will overdose and die.

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

In one study, the pill provided about the same pain relief to patients as IV morphine.

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