December 11, 2013
Could MDMA Become a Legal Drug in the USA?
Stoney Roads features a portion of the reddit Ask Me Anything session hosted by MAPS, looking at the timeline of research into treating posttraumatic stress disorder with MDMA-assisted psychotherapy. In response to a question about making this treatment more widely available, Amy Emerson of MAPS explains, “At least two Phase 3 studies are typically required to prove safety and efficacy before permission for prescription use can be approved.”
Originally appearing here.
In a recent AMA (Ask Me Anything) held on popular net culture trend site Reddit, the public had a chance to ask Amy Emerson, Director of Clinical Research at the Multidisciplinary Association for Psychedelic Studies (MAPS) anything about the drug research she had completed. An interesting question was raised by a Reddit user on the current research into the base chemical MDMA, the same chemical also commonly found in ecstasy and its use in the US and the prospect of it becoming a legal drug.
The user asked;
“With the current MDMA research, once that is finished is the expected result to get FDA (Food and Drug Association) to approve MDMA psychotherapy or is the plan to do even more research? What’s the current expected timetable for making this available for basically anyone that needs help in this way?”
…and the answer by Amy Emerson, Director of Clinical Research at the Multidisciplinary Association for Psychedelic Studies (MAPS);
“We are currently in Phase 2 of our clinical trials, this phase gathers preliminary information on the safety and efficacy of the drug to treat the condition under investigation in populations of 12 to 200 subjects. Phase 3 trials gather conclusive evidence regarding efficacy and safety in larger populations of 250 to 2000 subjects. At least two Phase 3 studies are typically required to prove safety and efficacy before permission for prescription use can be approved.”
The answer went on to detail the prospect of MDMA having the opportunity to become a pre-scripted drug by the year 2021 only after the sponsor of the studies submits a New Drug Application (NDA) to either the US based FDA and/or the European Medicines Agency.
What this means is, even with hard evidence it’ll still take a good amount of time – possibly years for the application to be submitted and approved by the US based FDA and other committees worldwide. Even with the changing trends and need for education with deaths at the hands of what is thought to be MDMA/ecstasy, usually cut with other terrible chemicals (bath salts, meth) to meet demand there isn’t a sense of urgency. Don’t expect to be able to grab your weekends pack of molly at the corner store either, clinical trials will usually come first and the medical world will most likely run their own tests.
In saying that though we need a quicker response to regulate and control who sells it and what is in it. Currently the black market is thriving by selling a product that has become a premium commodity without any safety for the end user.
Still, studies like the above by MAPS offer a glimmer of hope that lives can be saved and things such as MDMA can be used for positive measures.
Back to MAPS in the Media