FDA approves opioid painkiller 1000 times stronger than morphine

FDA OKs powerful opioid pill as alternative to IV painkiller

But U.S. Sen. Edward J. Markey, D-Mass., sharply criticized that vote, saying Dsuvia is an opioid painkiller up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine.

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis.

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. It's intended for short-term use only, and should not be used for more than 72 hours.

But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses.

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The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug. "That means it won't be available at retail pharmacies for patients to take home".

Last month, FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that Dsuvia be approved.

More: Drugs kill more Americans than guns, cars and AIDS. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds".

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.

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