FDA approves opioid stronger than fentanyl

FDA approves new opioid

The FDA just approved an opioid painkiller 10 times more powerful than fentanyl

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.

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine".

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. 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. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

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.

Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death.

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The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.

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.

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. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

"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.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.

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