Powerful new opioid approved for use in U.S.

Drug is 10 times more potent than fentanyl

WASHINGTON— The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.

The drug is five to 10 times more potent than pharmaceutical fentanyl. The tiny pill — just three millimetres in diameter — will probably worsen the drug crisis in the U.S., according to critics and the head of the FDA’s advisory committee on painkillers.

At the same time, 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. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need.

“We need to address the question that I believe underlies the criticism raised in advance of this approval,” Gottlieb wrote. “To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider … the epidemic of opioid misuse and abuse that’s gripping our nation?”

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

Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic — which killed a record 49,000 users in 2017, according to preliminary data — with the needs of people who need strong pain relief. But Friday’s statement is the first detailed indication of how the FDA might use its drug-review process to tackle the overall problem.

Gottlieb said he would bring a plan to the FDA’s opioid policy steering committee and perhaps Congress. The guidelines would allow the agency to consider a narcotic’s benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

“In this way, (drug companies) would know upfront where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness,” he wrote.

The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-yearold opioid commonly used after surgery and in emergency rooms. Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. Each would come in a plastic applicator that looks like a syringe.

The drug is intended for use within health-care settings and perhaps on the battlefield. It would not be available in retail pharmacies.

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. A spokesperson said the company is not providing information on expected sales.