MAPS PBC has begun collecting long-term follow-up data from previous study participants to determine the long-term safety and persistence of effectiveness of MDMA-assisted therapy at least 6 months after the last medication session. Because MDMA-assisted therapy is only administered 3 times and is not a chronic treatment, assessing and providing data on the long term treatment efficacy and safety will be a critical component of our New Drug Application (NDA) for MDMA-assisted therapy with the FDA.
