Zinger Key Points:

• Long-term follow-up (over 1 year) reflects continued improvement in symptom severity.

• The data confirm previous Phase 2 studies on the sustained effect of MDMA-assisted therapy on PTSD treatment.

• The New Drug Application (NDA) to be submitted in Q3 2023 would be the final step before the DEA reschedules the therapy.

The Legendary’s private arm Multidisciplinary Association for Psychedelic StudiesMAPS Public Benefit Corporation (MAPS PBC) announced positive top-line results from an observational follow-up of their two phase 3 studies on the llong-term safety and efficacy of MDMA-assisted therapy in PTSD.

The results show that participants experienced a sustained response within at least six months, and in some cases a year or more, after treatment with MDMA-assisted therapy.

“These results are consistent with previously published Phase 2 data showing the sustained effect of MDMA-assisted therapy at least 12 months after treatment, and suggest that the acute treatment effect could last even longer,” said Amy Emerson , CEO of MAPS PBC.

PTSD is a chronic condition that affects approximately 13 million Americans each year, producing general debilitating symptoms and often associated with serious comorbidities such as anxiety, depression, and substance use disorders (SUD).

All in all, it costs the health care system over $200 billion annually due to inadequate or inadequate treatments currently available.

Emerson says the condition has historically been treated with long-term maintenance therapy, “so it’s important to evaluate whether an acute treatment such as MDMA-assisted therapy has a lasting effect when used to treat PTSD.”

MDMA and steps forward

MDMA, an entactogen, or psychoactive drug, that causes one to experience emotional community, unity, connection, and openness, has a long history in the therapeutic field.

First used in the 1960s and 1970s in conjunction with psychological therapy to…