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posted by martyb on Wednesday March 06 2019, @11:00PM   Printer-friendly
from the depression-sucks dept.

Fast-Acting Depression Drug, Newly Approved, Could Help Millions

Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry. On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived from an old and widely used anesthetic, ketamine.

The move heralds a shift from the Prozac era of antidepressant drugs. The newly approved treatment, called esketamine, is a nasal spray developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, that will be marketed under the name Spravato. It contains an active portion of the ketamine molecule, whose antidepressant properties are not well understood yet. "Thank goodness we now have something with a different mechanism of action than previous antidepressants," said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. "But I'm skeptical of the hype, because in this world it's like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away."

[...] Esketamine, like ketamine, has the potential for abuse, and both drugs can induce psychotic episodes in people who are at high risk for them. The safety monitoring will require doctors to find space for treated patients, which could present a logistical challenge, some psychiatrists said.

The wholesale cost for a course of treatment will be between $2,360 and $3,540, said Janssen, and experts said it will give the company a foothold in the $12 billion global antidepressant market, where most drugs now are generic.

[...] One question that will need to be answered is how well esketamine performs in comparison to intravenous ketamine.

Also at STAT News, Reuters, and NPR.

Previously: Ketamine Reduces Suicidal Thoughts in Depressed Patients
Studies Identify How Ketamine Can Reverse Symptoms of Depression
Ketamine Shows Promise as a Fast-Acting Treatment for Depression

Related:


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  • (Score: 2, Interesting) by Anonymous Coward on Wednesday March 06 2019, @11:25PM (15 children)

    by Anonymous Coward on Wednesday March 06 2019, @11:25PM (#810920)

    That millions of people cannot cope with the reality without resorting to drugs?

    • (Score: 3, Funny) by Anonymous Coward on Wednesday March 06 2019, @11:33PM

      by Anonymous Coward on Wednesday March 06 2019, @11:33PM (#810924)

      Because we are the world's policeman and if we stop our hard work everything will go to shit.

    • (Score: -1, Troll) by Anonymous Coward on Thursday March 07 2019, @12:03AM (6 children)

      by Anonymous Coward on Thursday March 07 2019, @12:03AM (#810930)

      Why is antidepressant use so low in Japan and Iceland? Evidence does that when you mix races, no one is happy.

      • (Score: 2, Insightful) by Anonymous Coward on Thursday March 07 2019, @12:25AM (3 children)

        by Anonymous Coward on Thursday March 07 2019, @12:25AM (#810938)

        FTFY:

        Evidence does that when you mix races, racist sheep fuckers ruin things for everyone and no one is happy.

        • (Score: 1, Funny) by Anonymous Coward on Thursday March 07 2019, @01:36AM (2 children)

          by Anonymous Coward on Thursday March 07 2019, @01:36AM (#810963)

          Who said anything about Australia?

          • (Score: 3, Funny) by MostCynical on Thursday March 07 2019, @01:50AM (1 child)

            by MostCynical (2589) on Thursday March 07 2019, @01:50AM (#810969) Journal

            Or New Zealand.

            --
            "I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
      • (Score: 1, Insightful) by Anonymous Coward on Thursday March 07 2019, @12:51AM

        by Anonymous Coward on Thursday March 07 2019, @12:51AM (#810950)

        Your mistake is thinking lack of antidepressant use always necessarily correlates with lack of depression.

        But maybe suicide is a national issue in Japan because they're so happy from not taking anti-depressants.

      • (Score: 0) by Anonymous Coward on Friday March 08 2019, @04:25PM

        by Anonymous Coward on Friday March 08 2019, @04:25PM (#811581)

        Or maybe vulcanoes make you happy.

    • (Score: 1, Informative) by Anonymous Coward on Thursday March 07 2019, @12:24AM (2 children)

      by Anonymous Coward on Thursday March 07 2019, @12:24AM (#810937)

      Because US reality is depressing.

      • (Score: 0) by Anonymous Coward on Thursday March 07 2019, @12:27AM (1 child)

        by Anonymous Coward on Thursday March 07 2019, @12:27AM (#810939)

        Even if you're rich! You end up with the nagging feeling that you're ripping people off somehow and a genuine fear of razors b/c they look like small guillotines.

        • (Score: 2) by c0lo on Thursday March 07 2019, @01:27AM

          by c0lo (156) Subscriber Badge on Thursday March 07 2019, @01:27AM (#810960) Journal

          Even if you're rich! ... and a genuine fear of razors b/c they look like small guillotines.

          LOL
          And if you're not rich, it's depressing when you realize the razors aren't guillotines?

          So that, nation-wide, it boils down to: "Fuck Everything, We're Doing Five Blades" => "5 times as depressing", eh?

          --
          https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
    • (Score: 3, Informative) by Hartree on Thursday March 07 2019, @12:41AM

      by Hartree (195) on Thursday March 07 2019, @12:41AM (#810947)

      For my own case, Prozac has worked reasonably well for nearly thirty years. It's repeatable and dose dependent. If I go off of it, I start having symptoms again. Considering that in my family it's traceable back three generations on one side it's very likely genetic. Most likely, I could have been in any of the countries mentioned for low depression rates and still had major depression.

      If you want to feel that I just can't cope with reality, feel free.

    • (Score: 3, Interesting) by Anonymous Coward on Thursday March 07 2019, @03:10AM (2 children)

      by Anonymous Coward on Thursday March 07 2019, @03:10AM (#810990)

      Why is America depressing?

      Get off the island a bit and you'll see..

      Almost all the women are fat, entitled and not feminine.. and they want to be #meetoo's (cuz they get more attention that way despite being fat)
      Oh, and they think that to be 'equal', they have to behave like men (when they are not men).

      And the guys are jerks (because the above said women find that more 'attractive' so the guys end up that way (including me..lol)).

      Oh, and the oligarchy has robbed all the money.. the middle class is broke.. the pensions and savings are gone..

      Look at newsreals from the 1950s.. the women are thin and beautiful, dress nice and know how to use makeup. The guys are stylish, the cars are nice and things are new and clean.

      Then fast forward to today..
      Poverty, obesity, #metoo'isms.. oh, and lets not get started about all the illegals and H1b's too..

      How could you not get depressed? So many other countries are better and more fun than the USA these days, its nice that I am usually not there :-)

      • (Score: 0) by Anonymous Coward on Thursday March 07 2019, @04:16AM

        by Anonymous Coward on Thursday March 07 2019, @04:16AM (#811007)

        Maybe it was just my liberal as hell school but we were taught that everything you assume you should do in life, get a job, married, a car, kids, try to save extra money for your kids, is all evil. So all you are left with is nihilism, the metoo era, no jobs, and finding it that you are too old to start a family so they want to replace you with foreigners.

      • (Score: 1, Insightful) by Anonymous Coward on Thursday March 07 2019, @04:42AM

        by Anonymous Coward on Thursday March 07 2019, @04:42AM (#811015)

        Well, here's the thing.

        So, personally I would not mind neoliberal fascism that looks something like the film Starship Troopers. I will bet in that world, either there is no institutional sexual harassment ironically called sexual harassment "training," or else it would be required for everybody and not just those legally male.

        There is the old conservative trope of "feminazi." When criticized, a feminist will reach for a copy of The Second Sex, which is good and all. It should be required reading instead of the drivel we're shoveled in neoliberal indoctrination education. There is nothing in the works that feminist consensus would say are foundational that is ethically objectionable. In fact, it's quite the opposite. So that's feminist theory.

        #metoo is post-second wave feminism in practice. A simple accusation has the capacity to completely wreck a man's life, as in homelessness is a very real possibility. I will try to not weigh socialism vs. capitalism more than is necessary here... we currently live in a capitalist era, and the problems this creates for legal males are not only tremendous but further compounded by a legal and cultural system of justice that implicitly accepts the very gender paradigm argued against in The Feminine Mystique.

        And the thing is? Wombyns don't want that contradiction between the actualization of women's liberation and the philosophy upon which it is founded to ever be resolved. Feminism is, for the most part, a capitalist movement. It operates within capitalist dynamics. The dynamics of capitalism (viz. competition) dictate an "ends justify the means" mode of competition of labor for jobs that pay a living wage. That means if wombyns can go for low blows, they will, and they will do it consistently as long as it works.

        As the feminist movement in Sai King's callas might say, feminism has forgotten the face of its mother. It was influenced by Marxism, but it is not a Marxist movement. It also drifts farther and farther from its philosophical moorings which are, if not entirely Marxist (the right-wing feminists have always been with us), at the very least based on ideas of egalitarianism. Feminism is no longer about equality. And for the record, the word equity is being used by feminists to spread FUD place like Reddit and stuff about Google's recent investigation into the gender wage gap.

        Feminism cannot possibly be about equality without incorporating Marxist ideas at this stage of its material development. Instead, feminism has been subverted by capitalism, and it is about capitalist domination.

        I think I'm gaining an appreciation for the word cuck. Personally I have no uses for word used in sexual context, but in usage it is not always sexual. A cuck is somebody who falls for the propaganda and gaslighting upholding capitalist feminism.

  • (Score: 5, Informative) by Hartree on Thursday March 07 2019, @12:48AM

    by Hartree (195) on Thursday March 07 2019, @12:48AM (#810949)

    This works in a different way than the SSRIs like Prozac, but is unlikely to be a replacement for them and the other types of antidepressants (tricyclics, MAOIs, etc).

    We talk about depression as just one disease, but in reality, it's a set of symptoms. There are likely differences in what cause it from person to person and definitely are differences in the way the various antidepressants are metabolized. Different medications are going to work differently in different people. It's common that it takes several tries to find a medication that works for a given person. Esketamine is currently approved for those who don't get relief from the other ones. In time, it may become a front line treatment, but may well not depending on what we learn from larger numbers of people taking it.

    Until we have a better understanding of what actually causes the constellation of symptoms we call major depression, we're largely limited to try something and see if it works.

  • (Score: 2) by krishnoid on Thursday March 07 2019, @01:07AM (1 child)

    by krishnoid (1156) on Thursday March 07 2019, @01:07AM (#810954)

    Anyone have a pointer to any journal papers on this? I'd like to look through the related background research.

    • (Score: 3, Informative) by c0lo on Thursday March 07 2019, @01:48AM

      by c0lo (156) Subscriber Badge on Thursday March 07 2019, @01:48AM (#810968) Journal

      Couldn't find, but the nytimes FA [nytimes.com] reads:

      In each trial submitted, all patients were started on a new antidepressant drug, and given a course of esketamine treatment or a placebo. In one monthlong study, those on esketamine performed better statistically than those on placebo, reducing scores on a standard, 60-point depression scale by 21 points, compared to 17 points for placebo. But in two others trials, the drug did not statistically outperform placebo treatment.

      Hey-ho! At best, it's 6% more effective than a placebo. At worst, no better (for now)
      But forget the effectiveness, 'cause "a course of treatment will be between $2,360 and $3,540", the share-market will certainly rejoice. Oh, sorry, the price just doubled, literally. An errata at the end of TFA spells:

      Correction: March 6, 2019
      An earlier version of this article misstated the cost of treatment with esketamine. The correct cost is between $4,720 and $6,785, not between $2,360 and $3,540.

      ---

      Now, to be fair:

      All the subjects had been given a diagnosis of treatment-resistant depression, or T.R.D., having previously failed multiple courses of drug treatment.

      and

      Historically, the F.D.A. has required that a drug succeed in two short-term trials before it is approved; the agency loosened its criteria for esketamine, opting instead to study relapse in people who did well on the drug.
      In that trial, Janssen reported that only about one-quarter of subjects relapsed, compared to 45 percent of subjects who received the placebo spray.

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
  • (Score: 4, Insightful) by sjames on Thursday March 07 2019, @06:43AM (4 children)

    by sjames (2882) on Thursday March 07 2019, @06:43AM (#811060) Journal

    It's vastly more expensive than low dose ketamine AND it's less effective. Since it's only allowed to be given in a clinical setting, it doesn't really matter that it's a nasal spray rather than an IV drug. What's the point of it (other than being immensely profitable for the manufacturer)?

    • (Score: 0) by Anonymous Coward on Thursday March 07 2019, @10:41AM

      by Anonymous Coward on Thursday March 07 2019, @10:41AM (#811098)

      its immensely profitable for the manufacturer and can be patented.

    • (Score: 2) by quietus on Thursday March 07 2019, @06:26PM (1 child)

      by quietus (6328) on Thursday March 07 2019, @06:26PM (#811266) Journal

      It works near-immediately, apparently: patients feel better within an hour.

      • (Score: 2) by sjames on Friday March 08 2019, @12:19AM

        by sjames (2882) on Friday March 08 2019, @12:19AM (#811408) Journal

        So does the much cheaper low-dose ketamine (note, no e in front).

    • (Score: 0) by Anonymous Coward on Friday March 08 2019, @04:28PM

      by Anonymous Coward on Friday March 08 2019, @04:28PM (#811583)

      If you already use Ketamine the only correct response to this is to say neigh.

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