FDA approves new, powerful drug amidst opioid crisis

FDA approves new opioid

FDA approves new opioid

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.

The medication should not be used for more than 72 hours at a time, according to the FDA. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. 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. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.

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FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen.

An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said. The numbers say it all: More people die in the U.S. each year from drug overdoses than from breast cancer.

The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. A spokeswoman said the company is not providing information on expected sales. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. 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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