FDA approves opioid stronger than fentanyl

Florence Lopez
November 8, 2018

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public.

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 called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.

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.

But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia. "It can't be dispensed to patients for home use and should not be used for more than 72 hours". The most notable of these critics might actually be in-house: the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. In its newly approved form, it is an option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill.

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. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

LeBron James Not Fazed By Franchise-Worst First Quarter Vs. Raptors
Winners of just 27 games last season, the Kings are off to a respectable 6-4 SU start, powered by a recent five-game win streak. Pistons center Andre Drummond had 25 points and 24 rebounds in his team's 120-115 loss to the Heat.

Apple Sold 46.9 Million iPhones in the Last Quarter, Slightly Below Expectations
We recommend prospective investors wait for a more attractive margin of safety for this narrow-moat behemoth. The slide continued in pre-market trading Friday, with the stock falling 5.8 percent as of 7:15 a.m.in NY .

Blizzard announces Diablo Immortal mobile game
The events of Diablo Immortal are set after the events of Diablo 2: Lord of Destruction and before Diablo 3 . Q: How do you plan to stay relevant with a mobile game in a heavily PC-dominated market?

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".

"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement. Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted.

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. The numbers say it all: More people die in the U.S. each year from drug overdoses than from breast cancer.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

Other reports by

Discuss This Article

FOLLOW OUR NEWSPAPER