Wednesday, 21 November, 2018

FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

FDA approves powerful opioid despite fears of more overdose deaths FDA approves new opioid
Anna Jefferson | 07 November, 2018, 22:29

The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms.

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.

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said. "The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid", a statement from the public advocacy group Public Citizen said in response to the approval. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals.

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

More: Drugs kill more Americans than guns, cars and AIDS. 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 would not be available in retail pharmacies.

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.

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According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States.

The pills contain sufentanil, a chemical cousin of the opioid fentanyl. Writing in an October 18 letter to the FDA, Brown called the product "an extremely divertible drug", and predicted that diversion, abuse, and death would be observed within the first months of the drug's presence on the market. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

In approving the drug, the agency skirted its normal vetting process, these critics say.

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.

Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely".

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