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OnlineYthanA
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Psilocybin for major depression granted Breakthrough Therapy by FDA * 3
    #26346844 - 11/26/19 01:55 PM (4 years, 2 months ago)

Psilocybin for major depression granted Breakthrough Therapy by FDA
newatlas.com

The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD).

Back in late 2018, the FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin, the key psychoactive compound in magic mushrooms, as a therapy for treatment-resistant depression. A large, multi-center Phase 2 trial spanning the US, UK and Europe is currently underway testing a variety of dosing strategies.

This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder.

Last year’s Breakthrough Therapy designation was targeted at the drug’s efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD.

The new FDA approval focuses on Usona’s research into the broader condition of MDD, characterized by episodes of severe depression that last more than two weeks. Hundreds of millions of people around the world suffer from these kinds of acute major depressive episodes every year.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials,” says Usona’s director of clinical and translational research, Charles Raison. “What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies.”

The FDA’s Breakthrough Therapy designation was introduced in 2012 as a way of presenting a faster pathway to approval for drugs that display treatment advantages over current options for serious or life-threatening conditions. As well as offering developmental assistance to whatever organization is sponsoring the research, the designation is considered a positive endorsement towards the veracity and social impact of a prospective treatment. To date, roughly one in three treatments granted a Breakthrough Therapy designation have ultimately moved to market approval.

The Usona Phase 2 trial plans to enrol 80 subjects, randomized to receive either a single active dose of psilocybin or an active placebo containing niacin. The methodology being trialed is similar to other psilocybin therapy studies, with a number of preparatory psychotherapy sessions preceding the active psychedelic dose, and a number of integrative psychotherapy sessions afterwards.

As the trial is investigating the effects of a single psilocybin dose the research will offer some fascinating insights into the potential broad applications of the psychedelic agent in treating general depressive episodes, as opposed to other work exploring efficacy in more severe cases with multiple doses.

Usona estimates the current Phase 2 trial should be completed by early 2021, and with the help of this Breakthrough Therapy designation from the FDA, it should be able to swiftly move into larger Phase 3 trials if the results are positive.

The previously discussed COMPASS trials looking at psilocybin for treatment-resistant depression should be completed sometime in 2020, suggesting the next 12 to 24 months will offer some compelling and solid data into how effective this new psychedelic therapy actually is in treating several different forms of depression.

“Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices,” says Raison.


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Offlinemorrowasted
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: Ythan]
    #26347262 - 11/26/19 06:03 PM (4 years, 2 months ago)

this is real progress


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OfflineAeser
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: morrowasted] * 1
    #26348141 - 11/27/19 08:41 AM (4 years, 2 months ago)

It's funny. Imagine humans have known this for 1000s of years and in 2019 they call it "breakthrough". Glad to see the DEA/FDA have at least begun pulling a small portion of there heads out of there asses.


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Anxiety is when your stuck in the future.
Depression is when your stuck in the past.
Happiness is when your stuck in the present.


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Offlinejbgtaa
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: Aeser] * 1
    #26351091 - 11/28/19 08:04 PM (4 years, 1 month ago)

Quote:

Aeser said:
It's funny. Imagine humans have known this for 1000s of years and in 2019 they call it "breakthrough". Glad to see the DEA/FDA have at least begun pulling a small portion of there heads out of there asses.



i think you're misunderstanding the word "breakthrough" in this context.

In the medical feild. breakthrough therapy is anything that is used as a last resort that may be extreme, but is also extremely effective. Example, OxyCOntin and Fentanyl are classified by the FDA as "breakthrough" pain medication, only to be used when a pateint is in acute debilitating pain, and almost always works.


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OfflineFractal420
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: jbgtaa]
    #26351416 - 11/29/19 03:42 AM (4 years, 1 month ago)

That’s true. Breakthrough does not mean “new and cutting edge”. When referring to “breakthrough pain” in medicine, it means for example someone could be given Vicodin but when it gets really bad, they could be given Hydromorphone for “breakthrough pain” that isn’t controlled by the first medicine.

It’s kinda like how to be prescribed esketamine spray, you must first be on an antidepressant, and the ket is added on for when the ssri is not sufficient. Though it’s slightly different because it’s more specifically for treatment resistant depression, rather than a second working antidepressant

I have had my doubts about Compass for a while now, Maps as well (i see it as potentially corrupt intentions but perhaps leading to a positive result) but hey maybe I’m wrong and pharma is less involved than I thought. But there’s really no way to keep pharma (just like all the big corps) away from even CBD and they do make Marinol for a long time now. I wouldn’t want pharma to have control of mushrooms.

I would want them to be legal though and no crazy jail time for trying to grow a few grain jars. I mean that shit is just terrible and they call it “manufacturing” as If its a meth lab. You can’t make nature illegal, or you can but can’t really enforce such laws too extensively...however it’s still dangerous for DIY growers. The stakes for people who want/need psychedelics are so damn high. I wonder about that ALD52 case where the guy was telling the court he needed it for his mental health. This should be legitimate.

There must be a legit religion where mushroom use is legal...


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It's bright and blue and shimmering.
Grinning wide
And comforting me with it's three warm and wild eyes.

Prying open MY third eye



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OfflineShroomei
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: Fractal420]
    #26352432 - 11/29/19 05:04 PM (4 years, 1 month ago)

From FDA:

"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)..."

You won't get that designation e.g. for another type of diabetes treatment while a cure of diabetes might.

IMHO the naming actually alludes to an innovation leading to a breakthrough in treating a severe disease but in the end it is a name for a shorter version of red tape of drug registration.

That means for psilocybin that somebody invented the balls to clinically test an illicit drug and ask the FDA to speed up.


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InvisiblefeeversM
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: Shroomei]
    #26352446 - 11/29/19 05:11 PM (4 years, 1 month ago)

:fuckyeah:


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InvisibleHartford
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Re: Psilocybin for major depression granted Breakthrough Therapy by FDA [Re: Ythan]
    #26367329 - 12/07/19 04:36 PM (4 years, 1 month ago)

Psilocybin has to be reclassified as a schedule 2 drug therefore


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