FDA will be asked to approve MDMA for the treatment of PTSD in OCTOBER

As revealed, the Food and Drug Administration (FDA) is being asked to approve MDMA for medical use by October.

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.

The scientists behind the study are confident they will get approval and say there are likely to be no “tough questions” from regulators.

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

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

Patients take a standard dose of the drug under supervision. You will also be asked to wear a face mask and headphones. Sessions with a therapist then help people process their trauma (which depicts the process of MAPS)

It is estimated that nearly one in thirty-three Americans – or about eight million people – suffer from PTSD.

It was caused by experiences in conflict zones and major accidents that caused patients to have intense, disturbing thoughts and feelings related to their experiences.

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

Doctors currently try to treat the condition with powerful antidepressants, which suppress the immune system and cause a range of side effects, and some talk therapies.

Man who took 40,000 ecstasy pills and survived to tell the tale

Doctors estimate the 37-year-old from Surrey, England, took 40,000 ecstasy pills in nine years after being “very active on the club scene”.

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

However, MDMA is believed to help rewire connections in the brain, killing the part that scares people and allowing them to open up to a therapist and confront their trauma head-on rather than burying it.

The Multidisciplinary Association for Psychedelic Studies (MAPS), based in San Jose, California, told Nature that it will submit its latest findings for approval in October.

Dr. Rick Doblin, a Harvard-educated psychedelic expert, adds to the publication: “I don’t think there will be any hard questions or anything, the results are great.”

The FDA requires that at least two studies be submitted for a drug before it can decide on the drug’s approval.

MAPS completed the first study in 2021, a phase three clinical trial that enrolled 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 only psychotherapy and a placebo.

A second large study has now also been completed and, according to MAPS, again produced “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 a scientific journal in the coming months.

In the first study, patients received 80 or 120 mg of MDMA – or a placebo – which is about the amount in 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 80 mg or 120 mg of MDMA – the standard amount for one pill – plus an additional dose of 40-60 mg (stock photo)

Dr. Rick Doblin, a Harvard-educated psychedelic 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 share and process their experiences.

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

Experts worry that FDA approval of MDMA to treat PTSD 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 be legal in the US by 2024.

A spokesperson told the site: “We expect to file our non-disclosure agreement in Q3 2023 [July to September].

“Based on this estimated submission date, we expect possible approval in the second quarter of 2024 [April to June] and launching in the fourth quarter of 2024 [October to December].’