Psilocybin for major depression granted Breakthrough Therapy by FDA

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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.

Acid_Enthusiast on November 26th, 2019 at 21:50 UTC »

Psychedelics really can work wonders for people struggling with depression. I've had some amazing breakthroughs with LSD in the past. The last time I took it, when I was trying to sleep and had closed my eyes, near the end of the trip, I encountered my 15 year old self, back when I hid my Major Depressive Disorder from everyone and was so insecure about everything I said and did, and that version of myself was in a cage, begging me to "let him go," meaning he wanted me to let him commit suicide the way I tried when I was that age. I told him that, regardless of all his flaws, his mistakes he has and will make, I love him and forgive him for everything. When I realized what I was saying and who I was really saying it to, I sobbed uncontrollably for nearly 2 hours, but they were tears of relief that I was finally ready to move on, because that was probably the only time I ever said I loved myself the way I am and actually meant it. It was one of the most moving and emotionally fulfilling moments of my life, and it's helped me live life without worrying what others think of me, without punishing myself for my flaws and letting it control my self-image. I am eternally grateful for that moment

rddman on November 26th, 2019 at 18:55 UTC »

To be clear: this is psychedelic-assisted therapy: psychotherapy assisted by psychedelics - psilocybin in this case. There are also trials with MDMA. Without guidance (psychotherapy) it is not nearly as effective.

See

Multidisciplinary Association for Psychedelic Studies https://maps.org/

The Future of Psychedelic-Assisted Psychotherapy (2019) [16:32] https://www.ted.com/talks/rick_doblin_the_future_of_psychedelic_assisted_psychotherapy

Latest Developments In Psychedelic Science From MAPS https://www.youtube.com/watch?v=2q4VZUOGk2I

FDA Designates MDMA As 'Breakthrough Therapy' For Post-Traumatic Stress Aug 28 2017 Forbes https://www.forbes.com/sites/janetwburns/2017/08/28/fda-designates-mdma-as-breakthrough-therapy-for-post-traumatic-stress/

Michael Pollan: Magic mushrooms and LSD could help solve mental health crisis | ITV News https://www.youtube.com/watch?v=LHIUcch4ISc Michael Pollan, author of "How to Change Your Mind: The New Science of Psychedelics".

ShellOilNigeria on November 26th, 2019 at 17:18 UTC »

This is fantastic. I would like to see it federally legalized and available to people. I think micro-dosing will be something that has huge benefits for many people.

Anyone who isn't up psilocybin research should check out mycologist Paul Stamets speeches on the subject.

Serious research like in OP's link are happening at major universities and government labs all over the world right now.