
F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients (Nov 2016) - arikr
http://www.nytimes.com/2016/11/29/us/ptsd-mdma-ecstasy.html
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arikr
This happened yesterday (Tuesday 29th November 2016) afternoon. There was a
meeting with the FDA where they would give a verdict, and they gave approval
during that meeting.

Information explaining the significance from fruitsforhire

> Okay so here's a little background information on what this specifically
> means. It has taken 30 years to get to this point. MAPS has been around
> since 1986 with the main purpose of getting MDMA through the legal
> prescription system in the United States. Some extremely talented and
> dedicated individuals have made it their life goals to study MDMA (and other
> drugs as well) and to get them through the absurd regulatory hurdles Western
> nations have enacted since the War on Drugs.

> Phase 1 trials FDA trials for MDMA were greenlit in 1992, and Phase 1 trials
> are simply trials to assess safety in a small handful of individuals. It's
> just the step after animal safety trails. Preparation for Phase 2 and then
> subsequently Phase 2 is what has been going on for a decade or so which is
> small-scale human trials meant to start studying the actual effectiveness of
> the drug. It's all extremely expensive and complicated work building the
> foundation for Phase 3 trials which are absolutely massive in scale compared
> to anything else before at roughly 10 times as many people involved as Phase
> 2. It is one of the toughest and most rigorous prescription drug regulatory
> systems in the world. Phase 3 is going to take many years, and it'll cost
> tens of millions of dollars.

> Most drugs never even make it to Phase 2, but on top of that most never make
> it through Phase 3 either. This will be the last crucial many years and many
> millions of dollars that stand in the way of MDMA becoming a legal
> prescription medication.

> If you believe in this cause and have money to spare then I highly recommend
> donating. Phase 3 trials cost an immense amount of money to fund. MAPS is a
> non-profit organization, and the only one of its kind in the world.

> More information can be found at maps.org and mdmaptsd.org

