Sunday, February 26, 2017

MDMA in final phase of FDA-mandated tests

A campaign for FDA approval of MDMA enters final trials - Business Insider - Kevin Loria:

November 30, 2016 - After veteran Tony Macie came back from Iraq in 2007, he learned he had post-traumatic stress disorder [PTSD].... The retired sergeant then became part of a clinical trial organized by MAPS [Multidisciplinary Association for Psychedelic Studies] that was testing an unusual substance.... MDMA, ... the pure form of something commonly thought of as an illegal party drug - ecstasy.... 'One of the first things I said when it kicked in was, "This is what I've been looking for,'" Macie says....

"The trial Macie was involved in and other Phase 2 clinical studies conducted by MAPS have been so effective that the Food and Drug Administration on Tuesday agreed to allow large-scale Phase 3 clinical trials — the third and final in the three sets of human trials required before the FDA will consider a new drug for approval — to go forward, according.... If those trials continue to show that MDMA effectively treats PTSD, ecstasy could enter clinical use as soon as 2021, fitting the timeline that MAPS has been working toward for some time now....

"One of the early studies conducted by MAPS showed that 83% of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits stuck. That was a proof-of-concept study, with just 20 participants, all of whom had psychotherapy as well.... 

"Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials, which MAPS announced were coming to an end last March. These trials consisted of at least eight studies that Brad Burge, the director of communications for MAPS, recently told Inverse treated 136 people using MDMA-assisted psychotherapy for PTSD.... The data released from those studies so far is very promising, with a large percentage of patients not showing any signs of PTSD more than a year after completing the therapy.

 "The final tests will involve hundreds of people and must be conducted before the FDA decides to approve a new medication. 'Phase 3 starts around 2017, and it will take four to five years to finish,' Burge has previously said. 'So that will put it at early 2021 for FDA approval'....

"MAPS is mostly raising money itself to fund what it describes as a roughly $20 million plan to complete these trials, which are largely not of interest to pharmaceutical companies since the patent on MDMA has expired. That will mean significant fundraising is required.

"Last year the organization reported $9.1 million in assets, more than $5 million of which was a bequest from a longtime board member that has been earmarked specifically for those Phase 3 trials. In fiscal-year 2015, MAPS raised a combined $2.99 million from 2,500 donors. It said in its most recent annual report that 'substantially increasing our donor base' would be necessary to move forward with Phase 3 trials."

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