Ketamine-Nasal Spray Depression Treatment

Hopeful313

Hopeful313

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#1
Ketamine will be FDA approved by March 1st 2019 in the United States. It’s going to be demonstrated as a nasal spray where before it was as a fusion. Studies show that patients will see an effect within 2 hours if I am not mistaken. If it works, this will be revolutionary development for the mental health sufferers community.


 
Hopeful313

Hopeful313

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#3
Hi hopeful it’s saying video no longer available
I think it’s deleted for copyrights 😐
Is there away to upload it to the forum?

It’s an interesting news really. If it really works like they say, it will be a game changer.
 
Bizzarebitrary

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#5
I couldn't find the news item in the video but I'm assuming you're referring to Esketamine intranasal. Esketamine is a Ketamine derivative, unlike Ketamine it's patented. After clinical trials showed promising results the FDA advisory board recommended it for approval but the FDA will wait until March before deciding. Two of the five clinical trials failed to demonstrate positive effects above placebo which raises concerns.

I'm hopeful that it will be approved. I've been in Ketamine infusion treatment for a year and a half, it's had a huge positive impact on my symptoms. Still there are questions. Will the patent owner set the price of Esketamine at a level most patients can afford? Will insurance cover it? Will doctors prescribe it? I've learned that patients will need to have it administered by a clinician - it's not a take-home medicine. Will that increase the cost or require patients to travel great distances?

Will be depression patients with a history of substance abuse be excluded from this treatment?

In Europe, will the European Medicines Agency approve the Esketamine license application submitted last year? If so, how will Esketamine be integrated into current psychiatric practice in the UK and will doctors prescribe it? With just one clinic in all of England doing Ketamine infusion therapy as opposed to dozens in the States, we don't know how this treatment will be recieved.

Here's a recent US news article on the development.
 
Hopeful313

Hopeful313

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#6
Thanks for the correction.
I meant to write Esketamine. The report says it’s not a take home medicine and has to be administered by a doctor. The article you posted a link for said the FDA panel were skeptical about the affordability for patients but the news report said it will be covered by insurance. I am hoping that’s true.


You raise legitimate and reasonable questions. I don’t like the part where it says “The panel said the benefits of the nasal spray outweighed the risks.” then talking about hallucination and maybe disassociation as a side effect which by itself can trigger a new problem for patients.

It’s very important to know these side effects and risks such addiction. They don’t even mention anything about the possibility of long term use effects the medicine has on the brain and the neurological system.

For me things are confusing and can’t tell which of my mental health issues is debilitating me more than the other. Anxiety makes all other issues, like depression, seem easier to deal with and manage.

Would you try it if you have the chance to? @Bizzarebitrary

I am going to ask both my psychiatrist and psychologist about it and see what do they think.

Thanks the link @Bizzarebitrary
 
Bizzarebitrary

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#7
One of the reasons I don't write of my positive experience with Ketamine infusion therapy on this forum is because of these questions surrounding it. There are so many other pharmaceutical treatments to try, I think it's unwise to consider one that's both unproven and potentially risky for patients with certain disorders. However, treatment refractory patients do reach a point where all conventional options are exhausted and that's why I entered the program.

The panel said the benefits of the nasal spray outweighed the risks.” then talking about hallucination and maybe disassociation as a side effect which by itself can trigger a new problem for patients.
Indeed the potential dissociative effect alone may be completely intolerable for some. Patients with panic disorders for example. Though among us in the community who are receiving Ketamine treatment, we remind one another of some of the worst side effects we experienced while taking conventional antidepressants in various combinations before we started on Ketamine. There's no free ride, it's always weighing tolerability and risk factors against relief.

They don’t even mention anything about the possibility of long term use effects the medicine has on the brain and the neurological system.
You've hit on a major concern of doctors here. The data on long term effects of Esketamine or Ketamine isn't abundant. Then again, I don't know what the working definition of "long term" is for any new pharmaceutical. The corporation who developed Esketamine has been monitoring it's effects since at least 2015. I see that their clinical trials for studying long term effects aren't due to end until 2021.

Before I began Ketamine treatment I was given a series of examinations including an array of cognitive tests to measure any changes after 6 months in the program. No measurable changes, thankfully.

Anxiety makes all other issues, like depression, seem easier to deal with and manage.
Oh yeah, anxiety disorder is awful. A combination of Ketamine and cognitive therapies like DBT helped me get out of the grip of my GAD. One or the other alone could not have.

Would you try it if you have the chance to? @Bizzarebitrary
If I were not already receiving Ketamine infusions, yes I certainly would. But I'm not a typical example of a patient with MDD, I'm not even typical for treatment resistant depression. My symptoms resisted 9 different medications in 6 different categories of antidepressant. If I remember right the threshold for TRD is resistant to 2 medication categories?

And because I worry about how my words could be construed: to anyone considering scoring some K on the street, that is unsafe and not the same as treatment, it is self-medicating. Street Ketamine is far above the treatment dose and often cut with other chemicals, do not risk your health on it, this will not help you.

Thank you @Hopeful313 for sharing this topic and I appreciate you bringing critical thinking as well as optimism into the conversation.
 
Bizzarebitrary

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#8
The US FDA approved Sprovato (esketamine) today.
Here's what I know:

What's the differences between Ketamine and Esketamine?
Unlike Ketamine, esketamine is patented and owned by the company Jannsen, a Johnson & Johnson subsidiary. Esketamine is a variant of Ketamine. Ketamine has not been approved for use by the FDA for depression treatment but clinics have been using it as an off-label drug to treat MDD that's treatment-resistant for years.

How will patients get treatment?
Esketamine nasal spray will must be administered by a licensed clinic and patients will have to remain there for observation for 2 hrs after treatment. Clinics must be licensed or certified to administer the spray, Jannsen will provide training. It's unclear yet when patients will be able to take the nasal spray at home. Currently, patients who've been prescribed Ketamine intranasal spray can self-administered once proper dosage is determined.
What will Spravato cost?
Because Spravato is FDA approved, insurance companies will cover at least some of the cost of treatment whereas Ketamine is not covered by most plans. The esketamine treatments are expensive. There is not yet a generic formulation so it's unclear what the bottom line will be for depression patients. Jannsen is betting big on this drug.

Why is this big news?
Ketamine and esketamine work completely differently than the antidepressants currently on the market. It works on glutamate receptors. If effective, it will represent the biggest breakthrough in psychiatric medicine in decades and potentially help the 1/4 to 1/3 of us who do not respond to SSRI, SNRI, NDRI, TCA, and other varieties of conventional antidepressant medications.
Who can get this treatment?
The guideline says for a patient to be eligible for esketamine they must show resistance to two kinds of standard antidepressants. That's not a very high bar. It could even include patients who stopped taking a medication when it pooped out, we shall see. Also, not every psychiatrist and GP is super excited about this treatment and there are many who aren't ready to prescribe given that it us so different than other antidepressants.

Why I'm interested?
I'm an MDD-TRD patient. I've been in an experimental Ketamine infusion program for about 18 months. It is the only drug that's ever been effective at relieving my symptoms and I get treatment once a month. I do not receive intranasal, I get intravenus via injector pump and I'm getting Ketamine not Sprovato.
I am really excited that there's a chance for more of us to receive a new treatment for depression - but I'm cautiously optimistic, given that the cost of it hasn't been established. We know pharmaceutical companies want to make their money back from what they invested in R&D. On the other hand, I doubt that Jannsen would've invested so much into Sprovato if they weren't convinced of the potential of this treatment.

Outside the US
Jannsen applied for a license to market Sprovato from the European Medicines Agency last year. I imagine that a thumbs up from the US FDA is going to help their application along. Some doctors in the UK are voicing reluctance given how there isn't a protocol or standard by which patients are determined eligible and the presence of this new drug represents a disruption of accepted norms.
There is just one clinic in England that's offering Ketamine treatments (in Oxford, the treatment isn't covered by NHS it's private-only) which is relevant because a lot of doctors aren't familiar with the mechanism by which Esketamine or Ketamine are said to work on depression.

We shall see in the weeks to follow how Sprovato will be rolled out. It's certainly exciting news that there's a novel treatment for serious depression, it's been decades since the last.
If you have questions about the treatment and how it's going for me, feel free to PM me.
 
Hopeful313

Hopeful313

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#9
One of the reasons I don't write of my positive experience with Ketamine infusion therapy on this forum is because of these questions surrounding it. There are so many other pharmaceutical treatments to try, I think it's unwise to consider one that's both unproven and potentially risky for patients with certain disorders. However, treatment refractory patients do reach a point where all conventional options are exhausted and that's why I entered the program.


Indeed the potential dissociative effect alone may be completely intolerable for some. Patients with panic disorders for example. Though among us in the community who are receiving Ketamine treatment, we remind one another of some of the worst side effects we experienced while taking conventional antidepressants in various combinations before we started on Ketamine. There's no free ride, it's always weighing tolerability and risk factors against relief.


You've hit on a major concern of doctors here. The data on long term effects of Esketamine or Ketamine isn't abundant. Then again, I don't know what the working definition of "long term" is for any new pharmaceutical. The corporation who developed Esketamine has been monitoring it's effects since at least 2015. I see that their clinical trials for studying long term effects aren't due to end until 2021.

Before I began Ketamine treatment I was given a series of examinations including an array of cognitive tests to measure any changes after 6 months in the program. No measurable changes, thankfully.


Oh yeah, anxiety disorder is awful. A combination of Ketamine and cognitive therapies like DBT helped me get out of the grip of my GAD. One or the other alone could not have.


If I were not already receiving Ketamine infusions, yes I certainly would. But I'm not a typical example of a patient with MDD, I'm not even typical for treatment resistant depression. My symptoms resisted 9 different medications in 6 different categories of antidepressant. If I remember right the threshold for TRD is resistant to 2 medication categories?

And because I worry about how my words could be construed: to anyone considering scoring some K on the street, that is unsafe and not the same as treatment, it is self-medicating. Street Ketamine is far above the treatment dose and often cut with other chemicals, do not risk your health on it, this will not help you.

Thank you @Hopeful313 for sharing this topic and I appreciate you bringing critical thinking as well as optimism into the conversation.
My apologies for the late reply.

You’re well versed in your treatment. I appreciate your input and your straight forward thoughts and answers.

One of the major problems for me is I am very hesitant to try new treatments. I visit one the most popular clinics in in the state of MN and I think they will be one of the first clinics to get their hands on Esketamine.

I will ask my doctor to see what she thinks about it. I am thinking to wait and see results. Many people will probably post personal reviews on YouTube soon.
 
Hopeful313

Hopeful313

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#10
The US FDA approved Sprovato (esketamine) today.
Here's what I know:

What's the differences between Ketamine and Esketamine?
Unlike Ketamine, esketamine is patented and owned by the company Jannsen, a Johnson & Johnson subsidiary. Esketamine is a variant of Ketamine. Ketamine has not been approved for use by the FDA for depression treatment but clinics have been using it as an off-label drug to treat MDD that's treatment-resistant for years.

How will patients get treatment?
Esketamine nasal spray will must be administered by a licensed clinic and patients will have to remain there for observation for 2 hrs after treatment. Clinics must be licensed or certified to administer the spray, Jannsen will provide training. It's unclear yet when patients will be able to take the nasal spray at home. Currently, patients who've been prescribed Ketamine intranasal spray can self-administered once proper dosage is determined.
What will Spravato cost?
Because Spravato is FDA approved, insurance companies will cover at least some of the cost of treatment whereas Ketamine is not covered by most plans. The esketamine treatments are expensive. There is not yet a generic formulation so it's unclear what the bottom line will be for depression patients. Jannsen is betting big on this drug.

Why is this big news?
Ketamine and esketamine work completely differently than the antidepressants currently on the market. It works on glutamate receptors. If effective, it will represent the biggest breakthrough in psychiatric medicine in decades and potentially help the 1/4 to 1/3 of us who do not respond to SSRI, SNRI, NDRI, TCA, and other varieties of conventional antidepressant medications.
Who can get this treatment?
The guideline says for a patient to be eligible for esketamine they must show resistance to two kinds of standard antidepressants. That's not a very high bar. It could even include patients who stopped taking a medication when it pooped out, we shall see. Also, not every psychiatrist and GP is super excited about this treatment and there are many who aren't ready to prescribe given that it us so different than other antidepressants.

Why I'm interested?
I'm an MDD-TRD patient. I've been in an experimental Ketamine infusion program for about 18 months. It is the only drug that's ever been effective at relieving my symptoms and I get treatment once a month. I do not receive intranasal, I get intravenus via injector pump and I'm getting Ketamine not Sprovato.
I am really excited that there's a chance for more of us to receive a new treatment for depression - but I'm cautiously optimistic, given that the cost of it hasn't been established. We know pharmaceutical companies want to make their money back from what they invested in R&D. On the other hand, I doubt that Jannsen would've invested so much into Sprovato if they weren't convinced of the potential of this treatment.

Outside the US
Jannsen applied for a license to market Sprovato from the European Medicines Agency last year. I imagine that a thumbs up from the US FDA is going to help their application along. Some doctors in the UK are voicing reluctance given how there isn't a protocol or standard by which patients are determined eligible and the presence of this new drug represents a disruption of accepted norms.
There is just one clinic in England that's offering Ketamine treatments (in Oxford, the treatment isn't covered by NHS it's private-only) which is relevant because a lot of doctors aren't familiar with the mechanism by which Esketamine or Ketamine are said to work on depression.

We shall see in the weeks to follow how Sprovato will be rolled out. It's certainly exciting news that there's a novel treatment for serious depression, it's been decades since the last.
If you have questions about the treatment and how it's going for me, feel free to PM me.
Thanks for posting. I totally forgot about it. I’ve been waiting for it to get approved.
 
Hopeful313

Hopeful313

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#12
Yes. I wasn't eager to join the Ketamine program. What are some of the most important reasons why you're hesitant?
I am mostly worried about side effects. Like said :
Indeed the potential dissociative effect alone may be completely intolerable for some. Patients with panic disorders for example.
I’ve never had an experience with dissociation and I think if it happens it’ll open many doors to worse problems.

Another reason is addiction. I know myself well. I don’t want to get addicted.

Both reasons cause me to be anxious 🙂.
 
Bizzarebitrary

Bizzarebitrary

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#13
@Hopeful313 both reasons you mention are valid in my opinion. How one balances the risk with reward is very personal, I think.

On the matter of side-effects, I've come to understand that how I experience them can be vastly different from another person. And the same is true for any symptom of depression or anxiety. In both cases, what's considered to be tolerable is, for the most part, a strictly personal experience which is why knowing oneself - as you do - is an advantage.