Psycho-Babble Medication Thread 1103216

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Esketamine recommended by FDA panel

Posted by Hugh on February 13, 2019, at 10:04:48

Feb. 12, 2019
By Reuters

An experimental nasal spray, which has a compound similar to the 'club drug' ketamine, has been recommended as a new depression treatment by an advisory panel to the Food and Drug Administration Tuesday.

The influential panel voted 14-2 in favor of Johnson & Johnson's drug esketamine, a treatment developed to treat major depression in patients who have not benefited from at least two different therapies. The panel said the benefits of the nasal spray outweighed the risks. Side effects include dizziness, nausea and an unpleasant feeling of dissociation, according to the company. One member in the panel abstained from voting.

Esketamine is a variation of the anesthetic ketamine, which is also abused as a recreational party drug with the street name, Special K. Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but the researchers expect the nasal spray will take effect more quickly and be easier to use.

"I think esketamine has the potential to be a game-changer in the treatment of depression ... I use the term potential because the issues of cost and patient accessibility need to be addressed," said Walter Dunn, a panel member who voted in favor of the approval.

The nasal spray acts quickly, showing benefits after four hours. The hope is that the spray can help the 30 percent to 40 percent of patients with major depression who don't respond to antidepressants, most of which take at least four weeks to take effect. Currently, Eli Lilly's Symbyax is the only FDA-approved drug for treatment-resistant depression.

Major depressive disorder (MDD) affects over 300 million people globally, and attempted suicides in people with this condition is about 20-fold higher than that of the general population, according to the company.

However, depression is a tricky area of development. Patients in clinical trials often show a big placebo response, masking the efficacy of the drug being tested.

The FDA, although not mandated to follow the panel's recommendation, is expected to announce its decision on esketamine by March 4.

 

Re: Esketamine recommended by FDA panel

Posted by LarsHoney1 on February 13, 2019, at 11:55:02

In reply to Esketamine recommended by FDA panel, posted by Hugh on February 13, 2019, at 10:04:48

Thanks for sharing the Good news! The more treatment options available, the better. But I wonder if EsKetamine could be helpful for someone who wasnt helped by Ketamine.

Also, the accessibility issues with being prescribed EsKetamine... I believe I read it will only be allowed to be taken in a doctors office/hospital. That it wont be like a typical prescription you get filled at the pharmacy and take home with you. SAD!

 

Re: Esketamine recommended by FDA panel » Hugh

Posted by beckett2 on February 13, 2019, at 12:07:20

In reply to Esketamine recommended by FDA panel, posted by Hugh on February 13, 2019, at 10:04:48

Any word on its use for bipolar depression?

 

Re: Esketamine recommended by FDA panel

Posted by Radish on February 13, 2019, at 16:37:34

In reply to Esketamine recommended by FDA panel, posted by Hugh on February 13, 2019, at 10:04:48

I wonder how long it lasts or how often you have to have it administered

 

Re: Esketamine recommended by FDA panel » beckett2

Posted by Hugh on February 13, 2019, at 16:47:15

In reply to Re: Esketamine recommended by FDA panel » Hugh, posted by beckett2 on February 13, 2019, at 12:07:20

> Any word on its use for bipolar depression?

Not much is known about it, but there is a clinical trial currently underway in Europe.

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002669-20

 

Re: Esketamine recommended by FDA panel » LarsHoney1

Posted by Hugh on February 13, 2019, at 16:53:29

In reply to Re: Esketamine recommended by FDA panel, posted by LarsHoney1 on February 13, 2019, at 11:55:02

Meltingpot posted this about a friend of hers who wasn't helped by ketamine nasal spray, but was helped by esketamine.

http://www.dr-bob.org/babble/20180728/msgs/1101232.html

 

Re: Esketamine recommended by FDA panel » Hugh

Posted by beckett2 on February 14, 2019, at 16:50:01

In reply to Re: Esketamine recommended by FDA panel » beckett2, posted by Hugh on February 13, 2019, at 16:47:15

> > Any word on its use for bipolar depression?
>
> Not much is known about it, but there is a clinical trial currently underway in Europe.
>
> https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002669-20
>
>

Interesting. Thanks Hugh. Feeling alright is difficult for me to imagine separate from being hypomanic. These years, hypomania is frightening rather than super productive. But imagine feeling just ok!

I suppose efficacy depends on what causes an individual's depression. Didn't Meltingpot say it wasn't helpful? (I can't remember.)

Have you tried ketamine?

 

Re: Esketamine recommended by FDA panel » beckett2

Posted by Hugh on February 15, 2019, at 11:13:31

In reply to Re: Esketamine recommended by FDA panel » Hugh, posted by beckett2 on February 14, 2019, at 16:50:01

>But imagine feeling just ok!

Maybe we'll both get there one of these days.

>Didn't Meltingpot say it wasn't helpful? (I can't remember.)

Meltingpot said that a friend of hers was helped significantly by esketamine, but that it had taken her an unusually long time to respond to it -- over six weeks. Meltingpot's friend has a friend who was not helped very much by ketamine nasal spray.

>Have you tried ketamine?

No, I haven't.

 

Re: Esketamine recommended by FDA panel » Hugh

Posted by beckett2 on February 17, 2019, at 14:22:03

In reply to Re: Esketamine recommended by FDA panel » beckett2, posted by Hugh on February 15, 2019, at 11:13:31

Im keenly interested in psilocybin. My hunch is I could grow new thoughts. Compensating for a lifetime mood disorder damaged me in ways therapy hasnt touched. Mushrooms can produce gentle contemplation.

Id like this to happen before another ten years pass.

Where I live, theres underground availablity, but I havent mustered the will or courage. God forbid I take the wrong amount and have a grand mal panic attack. Ive done that a couple of times with mmj edibles. Not an experience to repeat.

 

Re: Esketamine recommended by FDA panel » beckett2

Posted by Hugh on February 19, 2019, at 16:53:47

In reply to Re: Esketamine recommended by FDA panel » Hugh, posted by beckett2 on February 17, 2019, at 14:22:03

Years ago, psilocybin lifted me out of a severe depression. It didn't put me into remission, but it would be a long time before I became severely depressed again.

The banned drug that interests me the most these days is MDMA. There's a fair chance that this will be approved by the FDA in 2021 for PTSD. I hope that it can be prescribed off label for other disorders, because I've read that underground therapists have been getting amazing results with Ecstasy-assisted psychotherapy. In one four-hour session, a patient can accomplish years' worth of talk therapy.

 

Re: Esketamine recommended by FDA panel » Hugh

Posted by beckett2 on February 22, 2019, at 12:45:46

In reply to Re: Esketamine recommended by FDA panel » beckett2, posted by Hugh on February 19, 2019, at 16:53:47

> Years ago, psilocybin lifted me out of a severe depression. It didn't put me into remission, but it would be a long time before I became severely depressed again.
>
> The banned drug that interests me the most these days is MDMA. There's a fair chance that this will be approved by the FDA in 2021 for PTSD. I hope that it can be prescribed off label for other disorders, because I've read that underground therapists have been getting amazing results with Ecstasy-assisted psychotherapy. In one four-hour session, a patient can accomplish years' worth of talk therapy.

Does one take a usual (street) dose or a micro dose? I have no experience with MDMA.

I've been reading along on the ketamine threads and becoming more interested. Since it was just approved, how long do you think until it's available? I would try it. My assumption it's a micro dose?

 

Re: Esketamine recommended by FDA panel » beckett2

Posted by Hugh on February 26, 2019, at 15:10:16

In reply to Re: Esketamine recommended by FDA panel » Hugh, posted by beckett2 on February 22, 2019, at 12:45:46

> Does one take a usual (street) dose or a micro dose? I have no experience with MDMA.

Not a microdose.

> I've been reading along on the ketamine threads and becoming more interested. Since it was just approved, how long do you think until it's available? I would try it. My assumption it's a micro dose?

It's a low dose, at any rate. Esketamine hasn't been approved yet, but the FDA will probably approve it by March 4. It should be available a few months later.


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