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OfflinemotamanM
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Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval * 1
    #25821466 - 02/18/19 05:40 PM (4 years, 11 months ago)

https://themighty.com/2019/02/fda-panel-ketamine-nasal-spray-approval-depression-suicide/?utm_source=newsletter_bpd&utm_medium=email&utm_campaign=newsletter_bpd_2019-02-15&fbclid=IwAR170GIoCaVHAeg2VWcY_xBzxYWqARuTvrwWIOe-4-jA5Zwxs6MVNv6fDLU

Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval


On Tuesday, a ketamine-based nasal spray moved one step closer to approval for use if you have severe depression or experience suicidal thoughts. If approved, it would be the first big medical breakthrough in mental health treatment in decades.

A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to two with one abstention to recommend the use of Janssen Research & Development’s new esketamine (brand name Spravato) nasal spray. The drug has been fast-tracked by the FDA with a “breakthrough therapy designation” because it shows signs of significantly improving available treatment options.

Ketamine was initially introduced as an analgesic for pain relief and is currently FDA approved for those purposes, according to UC San Diego Health. Per STAT News, by the 2000s, some studies showed ketamine may also be useful in treating depression. Researchers and drug companies have been chasing ketamine treatments ever since.

On Tuesday, a ketamine-based nasal spray moved one step closer to approval for use if you have severe depression or experience suicidal thoughts. If approved, it would be the first big medical breakthrough in mental health treatment in decades.

A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to two with one abstention to recommend the use of Janssen Research & Development’s new esketamine (brand name Spravato) nasal spray. The drug has been fast-tracked by the FDA with a “breakthrough therapy designation” because it shows signs of significantly improving available treatment options.

Ketamine was initially introduced as an analgesic for pain relief and is currently FDA approved for those purposes, according to UC San Diego Health. Per STAT News, by the 2000s, some studies showed ketamine may also be useful in treating depression. Researchers and drug companies have been chasing ketamine treatments ever since.

“The speediness of ketamine in producing an antidepressant effect occurs because this drug bypasses the traditional serotonin route and goes directly to activating glutamate,” psychiatrist Alexander Papp, MD, told UC San Diego Health. “This is very different from traditional antidepressants, which first increase the activity of serotonin in multiple different areas of the brain, and then ultimately affect glutamate. This process usually takes two to four weeks to take effect, while ketamine yields an almost immediate effect.”

Janssen — a Johnson & Johnson company — is the first to introduce a ketamine-based treatment for depression for approval. Esketamine, a “chemical cousin” of ketamine, was introduced in September 2018. The FDA fast-tracked its approval process for treatment-resistant depression, severe depression that doesn’t get better after taking several medications at their highest available dose for two or more months. It is also fast-tracked as a possible treatment for those with serious suicidal thoughts.

Based on three phases of clinical trials, including studies that tracked esketamine use up to 52 weeks, Janssen’s nasal spray was effective at treating depression in combination with a traditional antidepressant. The side effects were found to be minimal, including feeling disconnected, blurry or double vision, dizziness, nausea and increased blood pressure. Patients who received esketamine did so under the supervision of a medical professional to monitor their reactions and safety.

While ketamine has been available for at least 50 years, it became associated with recreational drug use and addiction, along with other hallucinogens like ecstasy and LSD. However, according to Bloomberg, a report provided to the FDA advisory panel called ketamine abuse “relatively uncommon,” lower than ecstasy and LSD.

Ketamine is currently labeled as a schedule III drug by the U.S. Drug Enforcement Administration (DEA). The DEA classifies drugs in five schedules according to their abuse potential and medical benefit. Schedule III drugs generally have “a moderate to low potential for physical and psychological dependence.” Anabolic steroids and testosterone are also schedule III substances. Cannabis and marijuana are classified in the highest-risk schedule I category.

The advisory panel did take the addiction risk of ketamine into account during its deliberations.

“Ketamine is a nasty drug,” Steve Meisel, a panel member and system director of medication safety at Fairview Health Services in Minneapolis, said, according to Bloomberg. “It’s been around for 50 years. Those of us who have seen it used know the adverse-event profile is large.”

Like the 14 panel members who voted to recommend esketamine for FDA approval, Meisel noted the positive response in patient surveys. He said it was crucial to consider patients in the drug approval process.

Other panel members noted esketamine’s potential benefit, particularly its fast-acting nature. Walter Dunn, a panel member and a psychiatrist at the West Los Angeles Veterans Administration Medical Center, highlighted this in his comment following the vote:

I believe esketamine has the potential to be a game-changer in the treatment of depression. The rates of response in this treatment-resistant population is better than we’ve seen. The rapid timeline of response is better. There’s nothing approved that gets patients better this fast.

Though the FDA does not have to follow the panel’s recommendation, reviews of previous approvals show that the FDA most often sides with the panel’s recommendations. The FDA is expected to make a decision on whether or not to approve esketamine by March 4.

Two other drug companies, Allergan and VistaGen, also have ketamine-based products in development for the treatment of depression.


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http://heffter.org


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OfflineMorel Guy
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: motaman]
    #25821566 - 02/18/19 06:41 PM (4 years, 11 months ago)

Great pre-treatment for shrooms!

My mom hates being high.  She thinks codiene makes her crazy.  She has sleep issues.  She thinks her ssri is great but it's annoying to me.  All chipper in the morning is no bueno!


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"in sterquiliniis invenitur in stercore invenitur"

In filth it will be found in dung it will be found


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Invisibletyrannicalrex
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: motaman]
    #25821802 - 02/18/19 08:59 PM (4 years, 11 months ago)

I've been seeing this firsthand for the last 2 years as a nurse in pain management.


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OfflineMorel Guy
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: tyrannicalrex]
    #25822183 - 02/19/19 06:13 AM (4 years, 11 months ago)

Usually they just put someone in a coma with a cocktail of anti-psychotics.


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"in sterquiliniis invenitur in stercore invenitur"

In filth it will be found in dung it will be found


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Invisibleellomello
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: Morel Guy]
    #25822545 - 02/19/19 10:49 AM (4 years, 11 months ago)

Cool to see medicine that works getting respect it deserves. Sad people have to be on the edge of suicide to get a dose.


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PAY NO ATTENTION TO THE MAN BEHIND THE CURTAIN get back to the garden

some came singing, some come to play, some come for keeping the dark away


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OfflineMorel Guy
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: ellomello]
    #25822582 - 02/19/19 11:10 AM (4 years, 11 months ago)

It's hard to tell when someone really is.  Most people are just afraid they are.

My mom almost killed herself and us.


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"in sterquiliniis invenitur in stercore invenitur"

In filth it will be found in dung it will be found


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Invisibleopenmind
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: motaman]
    #25822779 - 02/19/19 01:35 PM (4 years, 11 months ago)

Quote:

motaman said:
......according to Bloomberg, a report provided to the FDA advisory panel called ketamine abuse “relatively uncommon,” lower than ecstasy and LSD.







:rolleyes::rolleyes::rolleyes:


As far as I see....K is "abused" far more so than L or MDMA, and there is far more people addicted to K than there are people addicted to MDMA or LSD.


Not to make less of Ks potential to help with depression...I do agree it has a lot of potential to help with depression and if used responsibly & in moderation it is a pretty harmless drug, but to say it abused less than MDMA or L is a really silly & naive thing to say.






-OM

.


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OfflineMorel Guy
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: openmind]
    #25822991 - 02/19/19 03:36 PM (4 years, 11 months ago)

What constitutes abuse is a bunch of bullshit. There is no social program to legitimatize use if there was, it'd be exploited.

I just paid $170 for a cheeseburger at the ER.  They wanted almost $900.  I'll still get a doctor bill for his stupidity of not just saying "get out of here".


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"in sterquiliniis invenitur in stercore invenitur"

In filth it will be found in dung it will be found


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Offlinetacodude
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: Morel Guy]
    #25823753 - 02/19/19 09:14 PM (4 years, 11 months ago)

I have to agree ketamine is one of the more a usable drugs that has a narcotic effect that one could easily begin to crave. Personally long term I find NMDA antagonism just to create a sense of "IDGAF," which can be useful, but also very detrimental. I become inconsiderate and careless even from the NMDA antagonism in methadone. I really think this ketamine benifit is being blown out of proportion where it's an amazing medication to initiate treatment, but long term there are better and more direct options.


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Offlinesycodelix
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: tacodude]
    #25823827 - 02/19/19 10:00 PM (4 years, 11 months ago)

Been asking for k at the va hospital for a while... both 4 pain and fucked up head shit... they aren't giving it up...  love to take a squirt and jump in deprivation tank,  always wanted to try it, but think tank would be great...


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Offlinesycodelix
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: tacodude]
    #25823828 - 02/19/19 10:01 PM (4 years, 11 months ago)

Quote:

tacodude said:
I have to agree ketamine is one of the more a usable drugs that has a narcotic effect that one could easily begin to crave. Personally long term I find NMDA antagonism just to create a sense of "IDGAF," which can be useful, but also very detrimental. I become inconsiderate and careless even from the NMDA antagonism in methadone. I really think this ketamine benifit is being blown out of proportion where it's an amazing medication to initiate treatment, but long term there are better and more direct options.




Nmda? Not tracking...


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Invisiblebadchad
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: openmind]
    #25824185 - 02/20/19 06:45 AM (4 years, 11 months ago)

Quote:

openmind said:
, but to say it abused less than MDMA or L is a really silly & naive thing to say.

.




Except all the surveillance systems such as national surveys, poison center reports etc. suggest its true :shrug:


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...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436


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Invisibletyrannicalrex
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: sycodelix]
    #25824287 - 02/20/19 08:17 AM (4 years, 11 months ago)

I have gotten full coverage by some peoples insurance companies and this is for 10 days at 750 a day for a total of 7,500.00! Paid in full, but not too many. There are some insurances that pay for half that and variable amounts.


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Offlinetacodude
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: sycodelix]
    #25825794 - 02/20/19 05:46 PM (4 years, 11 months ago)

Quote:

sycodelix said:
Quote:

tacodude said:
I have to agree ketamine is one of the more a usable drugs that has a narcotic effect that one could easily begin to crave. Personally long term I find NMDA antagonism just to create a sense of "IDGAF," which can be useful, but also very detrimental. I become inconsiderate and careless even from the NMDA antagonism in methadone. I really think this ketamine benifit is being blown out of proportion where it's an amazing medication to initiate treatment, but long term there are better and more direct options.




Nmda? Not tracking...



What are you implying?


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Offlinesycodelix
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: tacodude]
    #25826386 - 02/20/19 09:54 PM (4 years, 11 months ago)

@tacodude

What is NMDA?


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InvisibleHolybullshit
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: sycodelix]
    #25827734 - 02/21/19 12:56 PM (4 years, 11 months ago)

If you think ketamine is abused more than MDMA or LSD that probably has more to do with the social circles you run in. Your average high schooler or college kid could score MDMA or some blotter with little effort, but that same kid has probably never even met someone who has done ketamine before. Most of them wouldn't even know what it is, or at most be familiar with the nomer "Special K", and knows it's used on cats.

I personally never had the urge to take ketamine very reguarly, of course I never tried doing just bumps of it and interacting with the world either. Went straight to loading up the rig and kissing reality goodbye; and I can't imagine doing that every night and keeping my sanity.

But I do gotta say if I were to receive a ketamine nasal spray bottle, and god knows I could use one, I would probably be tempted to crack it open and IM it; but AFAIK it would only have 1 real good dose in it. So I would hate myself afterwards thinking about how much benefit I could have gotten from it if used as intended.

With that said, I HIGHLY doubt anyone who hasn't previously abused ketamine AND is a straight up addict, would have the same urges. Ketamine isn't euphoric like stims and opies(although more euphoric than classical psychedelics) and with the doses used for depression being what they are, it just wouldn't be worth it.


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Offlinetacodude
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: sycodelix]
    #25828113 - 02/21/19 03:34 PM (4 years, 11 months ago)

Quote:

sycodelix said:
@tacodude

What is NMDA?



"The N-methyl-D-aspartate receptor (also known as the NMDA receptor or NMDAR), is a glutamate receptor and ion channel protein found in nerve cells. The NMDA receptor is one of three types of ionotropic glutamate receptors. The other receptors are the AMPA and kainate receptors. It is activated when glutamate and glycine (or D-serine) bind to it, and when activated it allows positively charged ions to flow through the cell membrane. The NMDA receptor is very important for controlling synaptic plasticity and memory function."

From Wikipedia


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Offlinetacodude
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Re: Breakthrough Ketamine Nasal Spray for Suicidal Thoughts and Severe Depression Closer to Approval [Re: Holybullshit]
    #25828134 - 02/21/19 03:43 PM (4 years, 11 months ago)

Quote:

Holybullshit said:
If you think ketamine is abused more than MDMA or LSD that probably has more to do with the social circles you run in. Your average high schooler or college kid could score MDMA or some blotter with little effort, but that same kid has probably never even met someone who has done ketamine before. Most of them wouldn't even know what it is, or at most be familiar with the nomer "Special K", and knows it's used on cats.

I personally never had the urge to take ketamine very reguarly, of course I never tried doing just bumps of it and interacting with the world either. Went straight to loading up the rig and kissing reality goodbye; and I can't imagine doing that every night and keeping my sanity.

But I do gotta say if I were to receive a ketamine nasal spray bottle, and god knows I could use one, I would probably be tempted to crack it open and IM it; but AFAIK it would only have 1 real good dose in it. So I would hate myself afterwards thinking about how much benefit I could have gotten from it if used as intended.

With that said, I HIGHLY doubt anyone who hasn't previously abused ketamine AND is a straight up addict, would have the same urges. Ketamine isn't euphoric like stims and opies(although more euphoric than classical psychedelics) and with the doses used for depression being what they are, it just wouldn't be worth it.


it's not that it is more commonly abused, but that it leads to regular use, dependency even if mainly mental, and something that one increases the dose to chase the dragon so to say. People might try to use MDMA regularly, but they learn fast how stupid that is. Same thing with daily high dose trips. Especially with IM/IV use having heavy association with abuse where people don't shoot psychedelics or mdma unless it's a novelty. Plus I'm wondering if you remember that girl that did a near quarter mile line of K to win a contest in a night club before collapsing and dying on the dance floor.... That was pretty much the end of Asian K. All I'm saying is to give someone something that has immediate effect that can be abused for use only for the long term benifit it could easily go downhill fast... Especially formulated as a nasal spray. Seriously what K head wanted so much K he pushed a ketamine spray for depression? This thing is literally made to be abused.


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