The Food and Drug Administration (FDA) will be asked to approve MDMA for medical use by October, it has been revealed.
This will pave the way for the drug to be available in hospitals before the second half of next year for treating post-traumatic stress disorder (PTSD).
Scientists behind the research are confident they will get approval, saying there are unlikely to be any ‘tricky questions’ from regulators.
Also known as ecstasy and molly, the drug is popular in rave culture, where it is used to dance all night long and feel ‘more connected’ to music.
But studies suggest it can also help people with Post-Traumatic Stress Disorder (PTSD), who suffer flashbacks and struggle to hold down work and maintain their personal lives.
Experts say the submission will pave the way for MDMA to be approved for use for PTSD patients before the second half of next year (stock image)
Patients take a standard dose of the drug while under supervision. They are also asked to wear a face mask and headphones. Sessions with a therapist then help people to come to terms with their trauma (image of trial provided by MAPS)
Nearly one in thirty-three Americans — or about eight million people — are suffering from PTSD, estimates show.
This has been triggered by experiences in conflict zones and serious accidents, leaving patients with intense, disturbing thoughts and feelings related to their experience.
At times, this can mean sufferers appear ‘vacant’ as they try to suppress a painful memory in their minds.
Medics currently try to treat the condition using harsh antidepressants which suppress the immune system and cause a range of side effects and 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, however, is thought to help 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 Multidisciplinary Association for Psychedelic Studies (MAPS), based in San Jose, California, revealed to Nature that it was submitting its latest results for approval in October.
Dr Rick Doblin, a Harvard-educated psychedelic expert, added to the publication: ‘I don’t think there’ll be tricky questions or anything, the results are great.’
The FDA requires at least two studies on a medication to be submitted before it can decide whether to approve the medication.
MAPS completed the first study in 2021, a phase three clinical trial involving 90 people with PTSD.
Results from this trial were promising, showing that people who received PTSD were twice as likely to recover from the condition as those who got just psychotherapy and a placebo.
A second large trial has now also been completed which MAPS says has, again, revealed ‘positive results’.
This study involves 100 people with PTSD, who received either MDMA-assisted therapy or a control. Its results will be published in a letter to an academic journal in the coming months.
In the first trial, patients were given either 80 or 120mg of MDMA — or a placebo — which is roughly the amount in the average ecstasy pill sold on the street.
Patients wore headphones and an eye mask during the treatment, as researchers sat with them for eight hours to oversee their reaction.
Clinical trial participants were given 80 mg or 120 mg of MDMA — the standard amount for a pill — plus a supplementary dose of 40-60mg
Dr Rick Doblin, a Harvard-educated psychedelics expert, said it was likely that the drug would get approved for medical use
They were also given a booster dose of 40 to 60mg about two hours into the session.
The next morning, each had a 90-minute session with a therapist who helped them talk about, and process, their experience.
Only Australia has approved MDMA for PTSD patients to date, with the drug expected to become available onwards from July 1.
Experts fear that if the FDA approves MDMA for treating PTSD then it could open the floodgates for other psychedelic treatments.
These include psilocybin — the active ingredient in magic mushrooms — LSD and ayahuasca.
Researchers at MAPS have previously told DailyMail.com that they expect MDMA to become legal in the US in 2024.
A spokesperson told this website: ‘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].’