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Groundbreaking Ketamine-Derived Treatment for Depression Approved by the U.S. FDA

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

takyon writes:

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:

Psychiatrists Investigate Using Mushrooms to Treat Depression
Research into Psychedelics, Shut Down for Decades, is Now Yielding Exciting Results
Depression Not Caused by Low Serotonin Levels - Most Drugs for Treatment Based on Myth
Psilocybin Successfully Treats Severe Depression in Small Clinical Trial
Research Into Psychedelics Continues
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Study Suggests Psilocybin "Resets" the Brains of Depressed People
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Amazonian Psychedelic May Ease Severe Depression, New Study Shows
Study Shows How LSD Alters Directed Connectivity Within Brain Pathways in Humans

Original Submission

 
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  • (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
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