Tuesday, 23 July, 2019

FDA approves new opioid

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Gustavo Carr | 07 November, 2018, 22:28

Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

Following the approval of Dsuvia, Gottlieb acknowledged that opioids are a unique class of medications. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program". But the committee's chair took the highly unusual move of voicing his opposition at that time. "This action is inconsistent with the charter of the agency", Brown said in a statement Friday.

The consumer watchdog group Public Citizen has also come out strongly against approval.

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours. The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. "That means it won't be available at retail pharmacies for patients to take home".

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USA regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

"To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider. the epidemic of opioid misuse and abuse that's gripping our nation?"

"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb said in his written statement.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks. 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.

There's more on pain control at the American Society of Anesthesiologists.