Do Existing Treatments Work?
Existing treatments are not always effective. Two selective serotonin reuptake inhibitors (SSRIs)—paroxetine (Paxil®) and sertraline (Zoloft®)—are currently marketed as PTSD medications in the U.S. These drugs must be taken every day for a long period of time in order to be effective, increasing the prevalence of side effects.
A third of PTSD patients do not respond adequately to established psychotherapies. 2 15 Cognitive behavioral therapies such as prolonged exposure and cognitive processing therapy, psychodynamic therapy, eye movement desensitization and reprocessing, and other psychotherapeutic treatments for PTSD are all similarly ineffective for some patients. 16
Even after treatment, over a third of PTSD patients still have symptoms. 7
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It meant the world to me to be able to look at the fear, to look at the shame…When I got out of that session, I felt a hundred pounds lighter…The drug gave me the ability not to fear fear.
– Donna Kilgore, PTSD patient and MDMA-assisted psychotherapy study participant
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We estimate that it will take $2 million and three years to be ready for our End-of-Phase 2 meeting with the FDA, and an additional $10 million and seven years to complete Phase 3 and establish MDMA-assisted psychotherapy as a legally available treatment.
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