MDMA could be available in US hospitals in 2024 after showing promise as a powerful treatment for PTSD.
Researchers behind a landmark federally funded trial told DailyMail.com they expect to submit a new drug application within months.
The US Food and Drug Administration will make a decision on approval perhaps as soon as six months later.
The move could see MDMA offered to some of the 12 million American adults 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 the night away and feel more connected to music and other ravers.
But it’s now part of a new frontier of psychedelics 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% went into remission after taking the drug along with therapy.
The second Phase 3 trial of MDMA therapy for PTSD in the United States concluded this month, testing the drug in patients whose PTSD isn’t as severe, as well as more people of color. . Data from the trial have not yet been released.
The Multidisciplinary Association for Psychedelic Studies (MAPS) — a nonprofit psychedelic awareness organization — is conducting the trials.
Patients take a standard dose of the drug under supervision. Sessions with a therapist then help people come to terms with their trauma
Participants in the clinical trial were given 80mg or 120mg of MDMA – the standard amount for one pill – plus an additional 40-60mg dose
A spokesperson told DailyMail.com: ‘We expect to file our NDA in the third quarter of 2023 [July to September].
‘Based on this estimated filing date, we anticipate 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.
FDA 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 fall.
The drug is likely to be administered in a clinic, the same way the trials were conducted.
Participants were given either 80mg or 120mg of MDMA, roughly the amount of an average ecstasy pill sold on the street.
The patients wore headphones and an eye mask, with a researcher sitting with them for eight hours to monitor their reaction. They then received a booster dose of 40 to 60 mg approximately two hours after the start of the session.
WHAT IS MDMA?
Ecstasy, chemically known as MDMA or molly, has been used by clubbers for decades due to its effects in helping to keep people awake.
It can come in the form of various pills and often takes around 30 minutes for its lasting effects to kick in, which can include feelings of love.
In the United States, the prison sentence can be up to 40 years in some states.
In the UK, possession of any form of ecstasy – considered a class A drug – is punishable by up to seven years in prison.
Drug activists warn that the biggest risk of taking MDMA revolves around the fact that many users don’t know what’s in the substance they’re taking.
It can include other drugs, such as PMA, which can be lethal at lower doses than MDMA itself.
The next morning they had a 90 minute session with a therapist who helped them talk and process their experience.
The results showed that 67% of the participants were no longer qualified for a diagnosis of PTSD after just three sessions of MDMA therapy. A total of 88% of people experienced significant improvements in their symptoms.
Current treatments for PTSD include harsh antidepressants that suppress the immune system and cause a range of side effects, as well as some talking therapies.
Although these drugs may help, they are not very effective in patients with severe PTSD and the results fade over time.
MDA is thought to rewire the connections in the brain, dulling the part that people are afraid of, allowing them to open up with a therapist and face their trauma head-on, instead of burying it.
The psychedelic also quiets the amygdala – the fear center in the brain – so people can rationalize their trauma and understand that they survived it.
Some 90 patients participated 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 “early 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 United States each year, and about 6% of the population will have it at some point in their lives.
A study in March this year from the University of California found that giving MDMA to people with PTSD doubled their chances of getting better with counseling.
Two-thirds of people with PTSD who received a 40mg dose of the party drug before treatment were disease-free after two months.
In contrast, one in three control group members who received only standard counseling were cured during the same period.
The MDMA combination even worked on patients with the most severe PTSD and those with drug and alcohol abuse problems, experts said.
The researchers said the “feelings of trust and closeness” caused by the drug helped them open up to psychiatrists and progress better.
If MDMA therapy is rolled out, it could open the floodgates for more psychedelics to come forward for approval.
Psilocybin, LSD and ayahuasca are all being tested in clinical trials.
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