Monday, 12 November, 2018

Ultra-Powerful Opioid Approved by FDA

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Francis Osborne | 08 November, 2018, 08:37

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

The drug is five to 10 times more potent than pharmaceutical fentanyl. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use.

The U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision.

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.

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

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It ended with an Afghan commando dead, although Rahimi declined to comment on whether this commando was a suspect in the killing. When he was ordered to deploy to Afghanistan in January, he announced that he would take a one year leave of absence as mayor.

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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. 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 previous year with 72,000 deaths - about 200 per day.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market.

The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

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