Therapy

Psychedelic Therapy Raises $30M Needed for FDA Approval

Researchers raised $30 million for MDMA-Assisted Psychotherapy to treat PTSD.

Posted Aug 24, 2020

Image by Gerd Altmann from Pixabay
Source: Image by Gerd Altmann from Pixabay

One of the most renowned psychedelic research centers in the world, the Multidisciplinary Association for Psychedelic Studies (MAPS) has raised $30 million to complete research into MDMA-assisted psychotherapy for Post Traumatic Stress Disorder (PTSD). Crowd-funded by prominent investors, philanthropists and the public alike, MAPS now has the funding it needs for the FDA to approve the first-ever psychedelic therapy for mainstream use. 

A long time has passed since the last revolution in mental health. And this couldn't be said more for Post Traumatic Stress Disorder (PTSD), a condition that affects at least 8 million people in the US and millions more worldwide. Currently, psychotherapy, also known as talk therapy, is considered the best treatment. Although it relieves some symptoms, up to 72% of patients still leave therapy with a clinical diagnosis of PTSD. 

It takes little to say that mental health- and treatment for PTSD- is a space ripe for disruption. And as it turns out, we are on the cusp of a major revolution. 

The advent of modern clinical trials for scheduled drugs from cannabis to LSD and MDMA is opening the floodgates to new horizons in mental health. While once keenly studied and used on tens of thousands of patients to treat everything from alcoholism to bipolar disorder and depression, research without special permission on these substances became outlawed after they fell victim to the War on Drugs in 1985. 

But not everyone agreed with this war. In a bid to prevent the potential of these drugs from being lost, Rick Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS). For over 34 years, he and his growing team have been studying multiple scheduled drugs- not just in the lab, but also in human clinical trials, and for some of the world's hardest-to-treat mental health conditions. 

Now, in a historic feat, the organization has raised $30 million from its Capstone Challenge to complete the final steps of its Phase III trials- the last stage of clinical testing- for MDMA-assisted psychotherapy for PTSD.

"We finally raised the $30 million we need to complete our Phase III trials- which is utterly amazing to us." says Doblin in a conversation with Psychology Today. "In the middle of the pandemic and a global financial meltdown, within a couple of months, we raised $30 million in multi-year pledges. And that'll be enough for us to get the treatment approved, assuming the data works out, in the US, Israel, and Canada."

To secure the funding, MAPS collaborated with the Psychedelic Science Funders Collaborative (PSFC), a group of philanthropists who believe psychedelic medicine and science could revolutionize mental health. Collectively, the group donated the majority bulk of the funds raised. 

"PSFC was the first group to bring Pharma investor level due diligence to psychedelic philanthropy," says Joe Green, co-founder, and President of PSFC, in a conversation with Psychology Today. "After surveying the field of psychedelic drug development, we decided to focus our support on MDMA for PTSD. Our analysis concluded that the capable MAPS team and their strong clinical data made them likely to be the first psychedelic therapy to get FDA approval." 

Aside from PSFC, MAPS also received over 2,500 donations from members of the public and prominent philanthropists, businessmen, investors, and public figures including Tim Ferriss.  

Impressed by the resounding results of psychedelic-assisted psychotherapies in existing research, Ferriss quickly realized that MDMA-assisted psychotherapy could redefine psychiatric treatment and mental health. 

"That was very interesting to me because I'm always looking for Archimedes levers- that is small points of leverage, where you can apply a little and get a lot out," says Ferriss, who famously made early-stage investments in companies such as Shopify and Alibaba.

Much like how philanthropist Catherine McCormick's donations of approximately $20 million in today's money were pivotal in the development of the contraceptive pill, Ferriss realized that a similar feat of revolution could be made for mental health with MDMA-assisted psychotherapy. As such, he spearheaded a funding challenge, featured Rick Doblin in his podcast, and personally pledged a million dollars to put his 'money where his mouth is'.

With all necessary funding now in place, FDA approval for MDMA-assisted psychotherapy is set to mark something of a psychedelic renaissance and the beginning of a new era for mental health. Although some psychedelics like ketamine have been approved in partial form as nasal spray Spravato for depression, and are available as an off-label treatment for patients to use at their own risk, so far no psychedelic has received FDA approval for mental health in its pure form. MDMA would, therefore, be a first.

So how does MDMA work? Despite its reputation as a party drug that can, in some cases, lead to hospitalization and even death from overheating or drinking too much water, researchers have found it to be an excellent facilitator in psychotherapy. 

By boosting serotonin levels, the drug increases feelings of happiness and wellbeing in patients. MDMA also boosts oxytocin levels in the brain, known as the 'love hormone', heightening feelings of trust and enabling social bonds. In this way, MDMA makes it easier for patients to form a strong bond with their therapist- a predictor of how successful treatment will be. 

But that isn't all it does. MDMA also reduces blood flow to the amygdala (the part of the brain that processes emotions) and the hippocampus (the brain's memory center) while increasing blood flow to the prefrontal cortex (the logical thinking part of the brain). This makes it easier for patients to access and process traumatic events without feeling intense pain. 

What's more, unlike in other psychedelics like magic mushrooms, LSD, and DMT, MDMA leaves the Default Mode Network (responsible for a person's sense of self) more or less intact, meaning that patients maintain their sense of 'self' or 'ego' throughout their experience. This makes MDMA more gentle than other drugs, which may involve losing one's sense of self. 

Lastly, the very nature of the MDMA experience makes cognitive restructuring (identifying irrational thoughts and ways to overcome them) come naturally to patients. More often than not, critical moments of trauma arise spontaneously while on the drug, alongside ways to reframe them- a process that is then enforced by their therapists.

By helping patients form bonds with their therapists and making cognitive restructuring come more naturally, MDMA helps create new neural pathways that override unhealthy ones in those with PTSD and other disorders. As such, MDMA-assisted psychotherapy is both able to vastly speed up treatment timelines and profoundly affect patients.

And until now, results from clinical trials have shown that the therapy has more impressive effects than any other treatment for PTSD. 

So far, studies by MAPS have focused on treating patients with chronic, treatment-resistant PTSD- those who have already had treatment but have not gotten better. Unlike other studies, MAPS also chose to include people who have attempted suicide. Taken together, the two criteria make these patients the most difficult cases to treat. 

In June this year, the organization released its full Phase II clinical trial results involving 107 people between April 2004 and March 2017 in the US, Canada, Switzerland, and Israel. Taking place in a series of six studies, the researchers compared patients undergoing MDMA-assisted psychotherapy to those taking either regular psychotherapy or a low dose of MDMA alongside psychotherapy. 

Each treatment took place over three and a half months with a combined male and female therapy team. Altogether, patients underwent three 8-hour long MDMA sessions with both therapists present. On either side of each MDMA session, patients also had three regular therapy sessions to help prepare and integrate their experiences. 

At the two-month follow-up, the researchers found that an average of 23% of those treated in the control groups no longer had PTSD- a figure comparable to other psychotherapies. However, the two-month follow-up for people who took higher doses of MDMA found that more than twice the number of patients no longer had PTSD- or 56% of those treated. 

While one person in the control group attempted suicide, throughout the study, none of the patients experienced psychotic reactions, nor addictive behavior to MDMA afterward.

Perhaps the most fascinating finding from the research, however, comes from the 12 month-follow-up. There, 67% of patients no longer had PTSD- a significant increase from the 56% at two months following treatment, meaning that patients actually continue to get better after the treatment. 

Doblin says this happens as MDMA-assisted psychotherapy teaches people strategies to process fearful emotions. Applying these strategies both during and outside of therapy ultimately means they no longer get overwhelmed by past traumas, whether they come up in memory or conversation. 

The study does note, though, that the researchers were not able to compare these results at the 12-month mark to those in the control group. This is because, after the 2-month follow-up, most people in this group began treatment with MDMA-assisted psychotherapy. 

Nevertheless, these results were still impressive enough for the FDA to declare MDMA-assisted psychotherapy a breakthrough treatment for PTSD in 2017, and to grant it an Expanded Access program in January 2020. This essentially means that people in serious or life-threatening conditions who do not qualify for trials can receive early access to the treatment. 

MAPS has just finished the first of their Phase III trials in the US and is in the midst of analyzing their initial results from a total of 90 patients. Overall, they are optimistic- and for good reason. An interim analysis of their data by an independent committee back in May found that they are more than 90% likely to deliver statistically significant results. 

To put that into perspective, the only other FDA-approved breakthrough therapy for PTSD was a repurposed sleeping pill called Tonmya. Theoretically able to reduce nightmares in people with PTSD, the drug failed its interim analysis in February. The drug company behind the pill was thus told to abandon their research. 

By comparison, the FDA was so impressed with MAPS's research that it allowed the organization to finish its current trial with 90 patients instead of the initially-agreed 100. 

Although previous estimates projected MDMA-assisted psychotherapy to receive FDA-approval by 2022, slow-downs due to COVID-19 have meant they have only been able to open four of their 11 phase III trial sites in the US. 

While over the next few months, the other US sites and those in Israel and Canada will be opening up, the hold-ups mean that approval will likely take another year. This means that even though all the data should be ready by mid-2022, FDA- approval may only happen by the end of 2022 or early 2023. 

Regardless of when the treatment will be fully certified, Doblin and others in the field are optimistic about the future. Once approved, they see that the therapy could both help millions recover from debilitating trauma and save people thousands, if not tens and hundreds of thousands of dollars, over their lifetimes on pills and other treatments. 

The desire to create a treatment for PTSD with long-term efficacy after a short treatment window is something that makes MAPS unlike most drug companies. Registered as a non-profit, the organization prioritizes curing people of mental health conditions, rather than symptomatically treating them with longterm drug regimens. 

Doblin has also said that once approved, he hopes that only the most severe cases will need to seek the treatment MAPS is running in trials. 

Meanwhile, his broader ambition is for psychedelics to be available for everyone as explorative tools- and not just as treatments for the very sick. Following further recognition, Doblin hopes that widespread approval of MDMA-assisted psychotherapy will open the floodgates to more use-cases for MDMA and other psychedelics. 

In a supportive environment after all, he says they may also be used as tools for personal growth, coming to terms with death, and feeling more connected to others and the environment. And this isn't just wishful thinking. These findings have been echoed from multiple recent studies. 

One study, for example, found that psychedelic experiences improve wellbeing and life satisfaction in 89% of people. Meanwhile, another study found that 67% of people say psychedelics account for one of their five most meaningful life experiences- if not the most meaningful. 

"I think people should keep an open mind about the value of psychedelics." says Doblin, "We will eventually end up with thousands upon thousands of psychedelic clinics all over the world. People there will not only be trained in psychedelics, but also in meditation, mindfulness, and yoga. In this way, we will be able to make a more spiritual humanity."

Although it may seem far-fetched, increasing interest in psychedelics among some of the world's leading research institutes from Johns Hopkins University to Imperial College London, and leading businessmen and investors alike, mean that this may well soon become a reality. 

And many would argue that this is exactly what we need- especially as countless studies have shown that mental health around the world has become increasingly fragile. The COVID-19 pandemic has only made this worse- putting us on what may well be a critical tipping point. 

The psychedelic renaissance, therefore, may have come just in time.