Update on the Status of Ketamine/Esketamine in the FDA Process

posted 6 months ago in Wellness
Post # 2
Member
2249 posts
Buzzing bee
  • Wedding: October 2019 - Chateau Lake Louise

sassy411 :  This is awesome news. As the sister of someone with severe PTSD, who had previously benefitted from MDMA used exprementally – but without an ongoing therapeutic context – ketamene has held the best hope for helping her cope. 

Thanks for sharing!

Post # 4
Member
1667 posts
Bumble bee

Very interesting news, thanks for sharing. 

Post # 5
Member
244 posts
Helper bee

sassy411 :  Thanks for the shout out. There are a few that should be getting approved quite soon, the most promising of which is psilocybin. To date, psilocybin (under medical supervision ofcourse ) has been the only successful treatment for my PTSD and I have obviously tried Ketamine, and MDMA doesn’t work on me at all for some reason, the MD running the trial thought it had something to do with my brain chemistry.

That all being said even with FDA approval, alot of people will be priced out of treatment. What will likely happen is it will be approved for therapeutic seasons which will still require high cost per season out of pocket. Take me for example, I have previously done my own research and can fly were I need to to get the treatment I need but expecting someone, to say, fly to SoCal because that is the only current practicitioner that is authorized to experiment with MDMA, in crazy unrealistic. I just don’t see that changing anytime soon. 

I see the same thing all the time with my endometriosis, women with money and resources get treatment and are in position in which they are valued enough that their employer understands while women with limited resources are treated like drug seekers, not believed, not referred to the best specialists, end up undergoing 4 to 5 surgeries when one or two would have been effective by a different more experienced surgeon.

I don’t know about everywhere else but having be on both sides of the class divide, medical treatments in this country are classist. Atleast from my experience.

Just because it is FDA approved treatment doesn’t make insurance cover it, otherwise I wouldn’t be spending $70/month on adderall to treat adhd.

Post # 6
Member
341 posts
Helper bee

Insurance would only cover it if it is FDA approved for a specific treatment (e.g. pediatric surgery). If it is being tested in a clinical trial for another treatment such as PTSD, depression, etc, then those individuals in the trial would probably get the drug paid for by the drug company, but the administration and anything that is considered standard of care would be the responsibility of the patient. 

Also, anything that is used off label, with the intention for it to be approved in the future, would be considered experimental and would require an IND (investigational new drug) application. Even tho it’s already FDA approved, it’s not FDA approved for what they are experimenting. It may be a different dosage, route of administration, adverse events, etc. Its fast tracked to get approved by Janssen which is great. We should hopefully see it approved and on the market in the next 5 years or so. 

Post # 7
Member
2526 posts
Sugar bee

sassy411 :  Have you run across anything related to using it as a treatment for fibromyalgia? My “all in my head” “discomfort” definitely messes with the rest of my body.

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