FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

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.

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. "It can't be dispensed to patients for home use and should not be used for more than 72 hours, and it will only be administered by a certified health care provider using a single-dose applicator", FDA Commissioner Dr. Scott Gottlieb tweeted Sunday. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

The FDA insists it is managing the opioid crisis and the new drug is needed by patients to manage pain.

"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.

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But those restrictions are not sufficient, claims Senator Ed Markey (D-MA), who blasted the FDA for failing to prove that the drug has enough "unique benefits over other available FDA-approved opioid products" to justify the risk of abuse. This includes potential uses on the battlefield.

"I am very disappointed with the decision of the agency to approve Dsuvia". Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing.

An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis".

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.

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