Article

2022-12-01 Science & Technology

MDMA 'will be rolled out in US hospitals by 2024': Researchers will submit trial data in MONTHS and start FDA approval process ‐ after rave drug 'cured' two-thirds of PTSD patients in study

[Daily Mail, where America gets its news]

Final trials have been completed, with an FDA application due mid next year

MDMA could be approved for therapeutic use just six months after that

Over two thirds no longer met the threshold for a PTSD diagnosis in clinical trials

The move could see MDMA offered to some of the 12 million American adults who suffer with post traumatic stress disorder (PTSD).

Also known as ecstasy or molly, the drug is popular in rave culture, where it is used to dance all night long and feel more connected to the music and other ravers.

But it has become part of a new frontier of psychedelics that are being repurposed as drugs for trauma and depression, along with ketamine, magic mushrooms and LSD.

A trial of 90 patients with severe PTSD in 2021 showed that 88 per cent went into remission after taking the drug accompanied by therapy.

The second phase 3 trial of MDMA therapy for PTSD in the US was completed this month, testing the drug on patients whose PTSD is not as severe, as well as on more people of color. Data from the trial is yet to be released.

The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) — an organization raising awareness of psychedelics — is running the trials.

A spokesperson told DailyMail.com: 'We anticipate filing our NDA in the third quarter of 2023 [July to September].

'Based on that estimated filing date we anticipate a possible approval in the second quarter of 2024 [April to June] and launch in the fourth quarter of 2024 [October to December].'

The latest study was completed ahead of schedule, meaning a New Drug Application could be submitted to the FDA by mid-2023.

The FDA's review teams could take just six months to approve the drug, meaning it could be approved as early as April 2024 and rolled out in the autumn.

The drug is likely to be given in a clinic, similar to how the trials were conducted. Participants were given 80 mg or 120 mg of MDMA — which is roughly the amount in the average ecstasy pill sold on the street.

Current treatments for PTSD include harsh antidepressants which suppress the immune system and cause a range of side effects, as well as some talking therapies. While these drugs can help, they are not very effective in patients with severe PTSD, and the results fade over time.

MDMA is thought to rewire connections in the brain, dampening the part that makes people scared, allowing them to open up with a therapist and face their trauma head on, instead of burying it. The psychedelic also quietens the amygdala — the fear center in the brain — so that people can rationalize their trauma and comprehend that they survived it.

Some 90 patients took part in the first phase 3 trial, and were randomly assigned to receive MDMA assisted therapy or a placebo, along with 12 therapy sessions.

A letter in May from the US Department of Health and Human Services reinforced the FDA's 'anticipated approval' of psychedelic therapies 'within approximately 24 months'.

PTSD can occur after a distressing event, and can cause flashbacks, nightmares and intense anxiety. The disorder affects 12 million adults in the US every year, and roughly six per cent of the population will have it at some point in their life.

Posted by Skidmark 2022-12-01 00:00|| || Front Page|| [11130 views ] Top

#1 We could have had this life-saving medicine decades ago if it weren't for Ken Kesey and Timothy Leary frightening the shit out of middle America with their bullshit. The most amazing medicine for mental health, and they convinced everyone it was just a recreational drug that was going to ruin the brains of impressionable youth.

They're responsible for millions of deaths and suicides due to mental illness.

Posted by Spike the Hairy6811 2022-12-01 01:42|| 2022-12-01 01:42|| Front Page Top

#2 Having a family member that survived a Baader Meinhof terrorist attack on a USAF storage bunker in Germany many years ago and seeing how F'd up his life has been since, PTSD sat in. I hope it works.

"MDMA is thought to rewire connections in the brain, dampening the part that makes people scared,.."

But with all that said. When we start playing with a person's mind chemistry, I have to wonder what possible deeper/wider implications it may bring.

Posted by NN2N1 2022-12-01 07:00|| 2022-12-01 07:00|| Front Page Top

#3 But with all that said. When we start playing with a person's mind chemistry, I have to wonder what possible deeper/wider implications it may bring.

See: Making boys stop acting like boys in grade school with pharmaceuticals.

Posted by M. Murcek 2022-12-01 07:47|| 2022-12-01 07:47|| Front Page Top

#4 Re: #3,

With what we've been through the last few years it's going to be a long, long time before I trust the Govt. or Pharma again.

Posted by AlanC 2022-12-01 11:40|| 2022-12-01 11:40|| Front Page Top

#5 "They're responsible for millions of deaths"

CIA or FBI - one of those agencies iirc was one of their main hook ups for acid.

Posted by mossomo 2022-12-01 12:26|| 2022-12-01 12:26|| Front Page Top

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