Amid deepening addiction crisis, FDA approves powerful new opioid

Lynn Cook
November 8, 2018

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

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". Also, Dr. Palmer argues that risk for abuse is low because it must be administered-again, by a health care professional in a controlled medical center setting-under the tongue. "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. The tiny pill - just three millimeters in diameter - is likely to worsen the nation's drug crisis, according to critics and the head of the FDA's advisory committee on painkillers.

In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders.

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One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. 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. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record past year with 72,000 deaths - about 200 per day.

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.

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Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. A spokeswoman said the company is not providing information on expected sales.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

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