An experimental medication for depression related to the hallucinogenic street drug ketamine won a crucial endorsement from an independent advisory committee convened by the Food and Drug Administration on Tuesday.

In a 14-to-2 vote, the panel said the benefits of the Johnson & Johnson drug, known as esketamine, outweigh the risks. The vote brings the novel type of rapid-acting treatment for depression one step closer to approval.

The drug — delivered in a nasal spray — is related to the anesthetic ketamine. If approved, it would be the first major depression treatment approved in decades. The drug was tested in combination with oral antidepressants as a therapy for treatment-resistant depression.

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“I believe esketamine has the potential to be a game-changer in the treatment of depression,” said Dr. Walter Dunn, a panelist and psychiatrist at West Los Angeles Veterans Administration Medical Center.

One panelist, Dr. Jess Fiedorowicz of the University of Iowa, abstained from the vote.

In its briefing submitted ahead of the hearing, the FDA expressed concern that patients could be harmed if they experience dissociation, or an out-of-body experience that can leave people less aware of their surroundings. The agency also noted six deaths — including three suicides — among patients who were taking the drug. But FDA reviewers said that given that it was just a handful of cases and the patients had severe illnesses, it’s “difficult to consider these deaths as drug related.”

Experts have also expressed concern that there might be a high potential for abuse, given that ketamine is commonly abused. But the committee — which voted 15-to-2 in favor of the drug’s safety profile — said that the risk of abuse appears to be low.

Members of the committee did emphasize the need for a robust strategy to prevent diversion, misuse, and other safety issues — and raised concerns about the need for more long-term data on esketamine’s effects.

“I don’t think we really understand what happens when you take this week after week,” said Steve Meisel, a panelist and the director of medication safety at Fairview Health Services in Minneapolis.

The FDA has granted esketamine a breakthrough-therapy designation. The panel’s vote will play a part in the agency’s decision on whether to approve the drug, expected by March 4.

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  • I’m a 6 year old woman who has suffered extreme depression my whole life. I’ve been on practically every SSRI made. I haveTardive Dyskinesia from taking Abilify. Nothing has helped. At all. I’m miserable. Since I live in a small town, (Toledo, Ohio), I’m more than certain that my psychiatrist would not even CONSIDER this new treatment. In my opinion, the reason people become addicts to any addicting substance, is because when you feel so horrible, EVERY SINGLE waking moment, they’ll try anything to feel better. No one starts out wanting to become an addict.
    I just wonder what insurance company will be willing to pay for this extraordinarily-priced drug.

    • Ok, I just reread my comment. I might ACT like a six-year old woman; actually I’m a 68-year old woman!

  • I’m glad to know that esketamine therapy for depression has benefits that outweigh the risks. I suppose I should look for services that are available in the area that offer this so that my sister can have the treatment she needs. If this is a potential game changer in the world of psychiatry, I might finally be able to see my sister smile again. https://ketaminedepressiontherapy.com/depression-therapy

  • Having spoken to some of the earlier researchers at a university research department, it looks like this is another gimmick that will be profitable for the pharma industry and the practitioners who peddle it.
    Emergenct rooms already “tested” Ketamine on unsuspecting patients , low income and minority patients without their knowledge. They also tested Ketamine on people with intractable chronic pain, they claimed it was “safer” than opiods. The people were left traumatized, dazed and confused after surgical proceedures, these results were not recorded.
    Dr Kieth Ablow famous TV psychiatrist adn Fx News commentator, found that Ketamine was a great drug for sexually abusing attractive patients. That added information may have helped speed the approval. The women were traumatized but they have no reported long term pysical side effects.

  • Hypertension and mental dissociation are dangerous side effects. Most ICU’s don’t use ketamine regularly. Looks like another temporary miracle drug.

  • According to the article, it was three suicides. The cause of the other three deaths is unspecified, except to say that the patients had severe illnesses. Suicide is a risk with all antidepressants. The depression itself can inhibit someone from taking an action like suicide. Lifting the depression can set in motion a plan that was already there, but not previously acted upon.

  • Only six suicides, that we know of. Like every other pych medication approved recently, this was most likely misreported. Since these medications are now prescribed by laypeople, inexperiancec practitioners, or perhaps even for punisment, all bets are off. We need a real scientific review board to look for irregularities in the research methods.

  • The FDA has also accorded ‘breakthrough’ status to psilocybin for psychiatric therapy which, unlike ketamine, is found in nature rather than in the laboratory and is thus more challenging to monetize in the way that Pharma inherently seeks to do. When will the FDA operationally facilitate the availability of promising treatments that do not lend themselves to similar commercialization but do offer plausible potential for addressing enormous suffering for large portions of the population?

  • All I can say-is look at the actual data carefully as to the effect after the acute response compared to standard care. IMO this should only be used in the in patient setting for severe depression and or suicidal thoughts. I am a psychiatrist-psychiatry has a long long history of getting out as they say-over its skis . Lets hope in the correct (controlled) setting this is a major advance and stands up to the test of time.

  • “The FDA has granted esketamine a breakthrough-therapy designation.”
    2, not just 1, BTD: the first in TRD, as discussed by today’s panel, the second in depressed patients at imminent risk of suicide, with a PhIII to read out this year.

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