During Tony's first MDMA session, he lay on the couch, he had eyeshades on, he listened to music, and he would speak to the therapists, who were a male-female co-therapy team, whenever he felt that he needed to. After several hours, in a moment of calmness and clarity, Tony shared that he had realized his PTSD was a way of connecting him to his friends. It was a way of honoring the memory of his friends who had died. But he was able to shift and see himself through the eyes of his dead friends. And he realized that they would not want him to suffer, to squander his life. They would want him to live more fully, which they were unable to do. And so he realized that there was a new way to honor their memory, which was to live as fully as possible. He also realized that he was telling himself a story that he was taking opiates for pain. But actually, he realized, he was taking them for escape. So he decided he didn't need the opiates anymore, he didn't need the MDMA anymore, and he was dropping out of the study. That was seven years ago. Tony is still free of PTSD, has never returned to opiates and is helping others less fortunate than himself in Cambodia.
The data that we presented to FDA from 107 people in our pilot studies, including Tony, showed that 23 percent of the people that received therapy without active MDMA no longer had PTSD at the end of treatment. This is really pretty good for this patient population. However, when you add MDMA, the results more than double, to 56 percent no longer having PTSD.
But most importantly, once people learn that if they don't need to suppress their trauma, but they can process it, they keep getting better on their own. So at the 12-month follow-up one year after the last treatment session, two-thirds no longer have PTSD. And of the one-third that do, many have clinically significant reductions in symptoms.
On the basis of this data, the FDA has declared MDMA-assisted psychotherapy for PTSD a breakthrough therapy. FDA has also declared psilocybin a breakthrough therapy for treatment-resistant depression and just recently approved esketamine for depression.
I'm proud to say that we have now initiated our Phase 3 studies. And if the results are as we hope, and if they're similar to the Phase 2 studies, by the end of 2021, FDA will approve MDMA-assisted psychotherapy for PTSD. If approved, the only therapists who will be able to directly administer it to patients are going to be therapists that have been through our training program, and they will only be able to administer MDMA under direct supervision in clinic settings. We anticipate that over the next several decades, there will be thousands of psychedelic clinics established, at which, therapists will be able to administer MDMA, psilocybin, ketamine and other psychedelics to potentially millions of patients. These clinics can also evolve into centers where people can come for psychedelic psychotherapy for personal growth, for couples therapy or for spiritual, mystical experiences.
Humanity now is in a race between catastrophe and consciousness. The psychedelic renaissance is here to help consciousness triumph