FDA will be asked to approve MDMA to treat PTSD this OCTOBER

The Food and Drug Administration (FDA) will be asked to approve MDMA for medicinal use by October, it has been revealed.

This paves the way for the drug to be available in hospitals for the treatment of post-traumatic stress disorder (PTSD) before the second half of next year.

Scientists behind the study are confident they will receive approval, saying there will likely be no “tough questions” from regulators.

Also known as ecstasy and molly, the drug is popular in rave culture, where it’s used to dance the night away and feel “more connected” to music.

But studies suggest it can also help people with post-traumatic stress disorder (PTSD), who experience flashbacks and struggle to manage their work and maintain their personal lives.

Patients take a standard dose of the drug under supervision. They are also asked to wear a face mask and headphones. Sessions with a therapist then help people process their trauma (image of process provided by MAPS)

Nearly one in thirty-three Americans — or about eight million people — suffers from PTSD, estimates show.

This has been caused by experiences in conflict areas and serious accidents, causing patients to have intense, disturbing thoughts and feelings related to their experience.

Sometimes this can mean that patients appear “empty” as they try to suppress a painful memory in their mind.

Doctors are currently trying to treat the condition using harsh antidepressants that suppress the immune system and cause a range of side effects and some talking therapies.

While these medications can help, they are not very effective in patients with severe PTSD and the results fade over time.

However, MDMA is thought to help rewire connections in the brain, dampening the part that scares people, allowing them to open up to a therapist and face their trauma head-on, rather than face it. to bury.

The Multidisciplinary Association for Psychedelic Studies (MAPS), based in San Jose, California, has revealed this Nature that it submitted its latest results for approval in October.

Dr. Rick Doblin, a Harvard-trained psychedelics expert, added to the publication, “I don’t think there will be any tough questions or anything, the results are great.”

The FDA requires at least two studies of a drug to be submitted before it can decide whether to approve the drug.

MAPS completed the first study in 2021, a phase three clinical trial involving 90 people with PTSD.

The results of this study were promising, showing that people who developed PTSD were twice as likely to recover from the condition as those who received psychotherapy and a placebo alone.

A second major trial has now also been completed and, according to MAPS, has again yielded ‘positive results’.

This study involved 100 people with PTSD who received either MDMA-assisted therapy or a control group. The results will be published in a letter to an academic journal in the coming months.

In the first trial, patients were given 80 or 120 mg of MDMA – or a placebo – which is about the amount of the average ecstasy pill sold on the street.

Patients wore headphones and an eye mask during treatment, while researchers sat with them for eight hours to monitor their response.

Clinical trial participants received either 80mg or 120mg of MDMA – the standard amount for a pill – plus an additional 40-60mg dose (stock image)

Dr. Rick Doblin, a Harvard-trained psychedelics expert, said it was likely the drug would be approved for medical use.

They also received a booster dose of 40 to 60 mg about two hours after the session.

The next morning, they each had a 90-minute session with a therapist who helped them talk about and process their experience.

Only Australia has so far approved MDMA for PTSD patients, and the drug is expected to be available from July 1.

Experts fear that if the FDA approves MDMA for the treatment of PTSD, it could open the floodgates for other psychedelic treatments.

These include psilocybin – the active ingredient in magic mushrooms – LSD and ayahuasca.

MAPS researchers previously told DailyMail.com that they expect MDMA to become legal in the US by 2024.

A spokesperson told this website: “We expect to submit our NDA in the third quarter of 2023 [July to September].

“Based on that estimated filing date, we expect potential approval in the second quarter of 2024 [April to June] and launch in the fourth quarter of 2024 [October to December].’