Published: Wed, November 07, 2018
Health Care | By Oscar Goodwin

Ultra-Powerful Opioid Approved by FDA

Ultra-Powerful Opioid Approved by FDA

The Food and Drug Administration (FDA) approved a highly controversial opioid.

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin. The medication, which comes in a single-use package, also should not be used for more than 72 hours.

"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said.

The United States continues to struggle with the opioid abuse epidemic. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer. 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 is committed to bringing a plan the FDA's Opioid Policy Steering Committee and maybe even the 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. "It's not a new drug; It's a new dosage".

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The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. Each would come in a plastic applicator that looks like a syringe. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it. A spokeswoman said the company is not providing information on expected sales.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.

An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12.

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 a year ago, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.

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"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. "It will be taken by medical personnel and others for whom it has not been prescribed".

"This action is inconsistent with the charter of the agency", wrote Brown, who is also a professor of anesthesiology and pediatrics at the University of Kentucky's medical school. Therefore, if there is any diversion, then the risk is among the medical personnel themselves, no one else.

A 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration shows that narcotics are rarely stolen from doctor's offices, clinics, hospitals or pharmacies. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids. Although the FDA has pledged to curb the on-going crisis, the statement made by the commissioner gives a clear insight as to how the agency will be moving forward with its drug evaluations.

Gottlieb said military use of the drug was "carefully considered in this case" as the FDA wants to "make sure our soldiers have access to treatments that meet the unique needs of the battlefield".

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments.

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