The safety and efficacy of MDMA-assisted therapy is currently under investigation. It is not yet approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings.
PTSD affects millions of people worldwide
9M adults in the US suffer from PTSD every year
350M+ people suffer from PTSD worldwide
Sources: US Prevalence: Kessler, et al., Prevalence, severity, and comorbidity of 12-month DSM IV disorders in the National Comorbidity Survey Replication, Archives of Gen Psych, 2005. Global Prevalence: https://www.uptodate.com/contents/posttraumatic-stress-disorder-in-adults-epidemiology-pathophysiology-clinical-manifestations-course-assessment-and-diagnosis PTSD War Population: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394282/pdf/zept-10-1578637.pdf
Why MDMA?
MDMA is capable of inducing unique psychopharmacological effects, such as:
Decreased feelings of fear and defensiveness
Increased feelings of wellbeing
Increased sociability and extroversion
Increased interpersonal trust
An alert state of consciousness
MAPS is currently sponsoring MAPP2, the second of two Phase 3 trials to support FDA approval of this Breakthrough-designated therapy.
In our first Phase 3 study, 67% of participants with severe PTSD no longer met PTSD diagnostic criteria two months after their third session of MDMA-assisted therapy, compared to 32% of placebo participants.
Additionally, 33% of participants in the MDMA group compared to 5% of participants in the placebo group met the criteria for PTSD remission after three sessions.
MDMA-assisted therapy is delivered during three 8-hour sessions, scheduled three to five weeks apart, along with 12 non-drug therapy sessions to aid with preparation and integration.
MDMA is a triple reuptake inhibitor that produces anxiolytic and prosocial effects through the release of neurotransmitters such as serotonin, norepinephrine, and dopamine.
MDMA also increases the release of oxytocin and prolactin (hormones associated with trust and bonding) as well as hormones that influence the HPA axis and stress response.
MDMA decreases activity in the left amygdala (associated with fear and trauma) which may allow patients to more openly discuss their memories in therapy.
Revenue share payments will be based on North America sales of MDMA for use in MDMA-assisted therapy, will terminate after 8 years, and include a reciprocity payment structure that reduces payments once …
We’ve finally reached the point where we can shout our good news from the roof tops and publicly celebrate the work of this amazing team! The publication of our MAPP1 findings is official as of this …
A Phase 1/2 open-label treatment development study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in dyads in which one member has chronic posttraumatic stress disorder (PTSD) shows MDMA-Assisted …
On December 20, 2019, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on MAPS’ proposed Expanded Access protocol for MDMA-assisted psychotherapy for posttraumatic stress disorder …
On October 15, 2019, the U.S. Food and Drug Administration (FDA) responded to MAPS with a continued clinical hold with safety concerns regarding the submitted protocol for an Expanded Access program for …
On July 12, 2019, MAPS received a response from the U.S. Food and Drug Administration (FDA) regarding the submitted protocol for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic …
In June 2019, MAPS responded to the U.S. Food and Drug Administration’s (FDA) continue clinical hold letter regarding the submitted protocol for an Expanded Access program for MDMA-assisted psychotherapy …
In May 2019, the U.S. Food and Drug Administration (FDA) sent a formal response to MAPS regarding the submitted protocol for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic …
In April 2019, MAPS Public Benefit Corporation (MAPS PBC) sent a response to the clinical hold letter received by the U.S. Food and Drug Administration (FDA) regarding the submitted protocol for an Expanded …
In March 2019, MAPS Public Benefit Corporation (MAPS PBC) received a clinical hold letter from the U.S. Food and Drug Administration (FDA) regarding the submitted protocol for an Expanded Access program …
In January 2019, MAPS Public Benefit Corporation (MAPS PBC) sent a formal protocol to the U.S. Food and Drug Administration (FDA) for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic …
In May 2018, the sixth dyad completed their long-term follow-up interview in our study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for posttraumatic stress disorder (PTSD) at our …
