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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:

Original Submission

1. "takyon" - https://soylentnews.org/~takyon/
2. "Fast-Acting Depression Drug, Newly Approved, Could Help Millions" - https://www.nytimes.com/2019/03/05/health/depression-treatment-ketamine-fda.html
3. "16 million American adults" - https://www.nimh.nih.gov/health/statistics/major-depression.shtml
4. "as many as one-quarter" - https://www.ncbi.nlm.nih.gov/pubmed/24789696
5. "developed by Janssen" - https://www.janssen.com/
6. "STAT News" - https://www.statnews.com/2019/03/05/fda-approves-esketamine-antidepressant/
7. "Reuters" - https://www.reuters.com/article/us-johnson-johnson-fda/jj-nasal-spray-gets-u-s-approval-as-first-new-type-of-anti-depressant-in-decades-idUSKCN1QN04J
8. "NPR" - https://www.npr.org/sections/health-shots/2019/03/05/700509903/fda-clears-esketamine-nasal-spray-for-hard-to-treat-depression
9. "Ketamine Reduces Suicidal Thoughts in Depressed Patients" - https://soylentnews.org/article.pl?sid=17/12/16/1425213
10. "Studies Identify How Ketamine Can Reverse Symptoms of Depression" - https://soylentnews.org/article.pl?sid=18/02/18/0244214
11. "Ketamine Shows Promise as a Fast-Acting Treatment for Depression" - https://soylentnews.org/article.pl?sid=18/04/16/2221228
12. "Psychiatrists Investigate Using Mushrooms to Treat Depression" - https://soylentnews.org/article.pl?sid=14/11/30/159231
13. "Research into Psychedelics, Shut Down for Decades, is Now Yielding Exciting Results" - https://soylentnews.org/article.pl?sid=15/02/11/1319211
14. "Depression Not Caused by Low Serotonin Levels - Most Drugs for Treatment Based on Myth" - https://soylentnews.org/article.pl?sid=15/04/23/1657231
15. "Psilocybin Successfully Treats Severe Depression in Small Clinical Trial" - https://soylentnews.org/article.pl?sid=16/05/18/0245204
16. "Research Into Psychedelics Continues" - https://soylentnews.org/article.pl?sid=16/11/30/1429259
17. "What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry" - https://soylentnews.org/article.pl?sid=17/03/11/1917229
18. "Study Suggests Psilocybin "Resets" the Brains of Depressed People" - https://soylentnews.org/article.pl?sid=17/10/14/1238206
19. "FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials" - https://soylentnews.org/article.pl?sid=17/08/30/0255213
20. "Amazonian Psychedelic May Ease Severe Depression, New Study Shows" - https://soylentnews.org/article.pl?sid=18/07/04/0157223
21. "Study Shows How LSD Alters Directed Connectivity Within Brain Pathways in Humans" - https://soylentnews.org/article.pl?sid=19/01/30/059238
22. "Original Submission" - https://soylentnews.org/submit.pl?op=viewsub&subid=32172

printed from SoylentNews, Groundbreaking Ketamine-Derived Treatment for Depression Approved by the U.S. FDA on 2024-04-25 13:41:52