FDA approves opioid painkiller 1,000 times stronger than morphin
08 November, 2018, 08:34 | Author: Norman Carr
Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that's said to be 10 times more powerful than fentanyl.
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".
Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said.
Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.
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.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.
Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg. Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments.
The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. A spokeswoman said the company is not providing information on expected sales. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".
"It's a huge mistake", Wolfe said. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.
Including brand name and generic drugs, there are almost 400 opioids now on the market.
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