Baby steps for MDMA

FDA to weight psychedelic-assisted therapy

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MDMA is one step closer to becoming the first FDA-approved psychedelic drug. In October 2023, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced it completed its phase three clinical trial of MDMA-assisted therapy for PTSD (Weed Between the Lines, “Relief MAPS” Oct. 19, 2023). 

The trial was an indisputable success. The results, published in Nature, showed that 86.5% of the 52 participants treated with MDMA achieved a clinically meaningful benefit, and 71.2% no longer met the criteria for PTSD by the end of the 18-week study. 

The successful trial seemed to justify everything MAPS and its founder, Rick Doblin, have been working toward since 1986. Doblin confidently predicted that sometime in 2024, the FDA would approve the drug for PTSD therapy.

On Dec. 13, progress toward that milestone moved forward. MAPS submitted the first-ever FDA New Drug Application (NDA) for MDMA-assisted therapy for PTSD. If it’s approved, the Drug Enforcement Agency (DEA) would have to reschedule MDMA accordingly.

“This milestone is a testament to the unwavering dedication and belief in our mission by thousands,” Doblin wrote in a press release

MDMA (3,4-methylenedioxymethamphetamine), also known as ecstasy or molly, has a long strange history in the U.S. It was first synthesized in 1912 by the drug company Merk and was originally called “Methylsafrylamin.” 

Medical literature suggested for decades that it was first patented as an appetite suppressor. (A review of Merk’s historical archive put that myth to rest in 2006.) At the time of its creation, MDMA was almost completely dismissed as an unimportant precursor to synthesize other hemostatic substances, which are used to prevent blood clotting in surgery. Merk didn’t even test MDMA’s properties until 1927 and then again in 1959 — and they didn’t test it on humans. 

It wasn’t until the 1970s that MDMA would be revisited pharmacologically. When it was, people immediately recognized its psychological benefits. It was used to enhance psychotherapy until the ’80s, when it was adopted as a party drug by the rave and dance scenes. 

In 1985, the DEA classified MDMA as a Schedule I drug, lumping it in with crystal meth, marijuana, LSD, psilocybin, mescaline and many others. According to the feds, MDMA is dangerous, has no known medicinal value and has a high potential for abuse. 

At least that’s the agency’s stance for now. Should the FDA approve MAPS’ recently filed NDA, the DEA would have to change that position.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, chief executive officer, MAPS PBC, a subsidiary of MAPS, said in a press release

Australia rescheduled MDMA in June 2023 to make it available for therapeutic use with a prescription. The government manages the sale, manufacturing and use of the drug, limiting the chances that prescribed users will encounter tainted or cut MDMA to almost zero. 

Here in the U.S., if the FDA doesn’t end up approving MDMA for prescription use, MAPS could help pave the way for other psychedelics to make their own appeals once they have the science to back their case up, according to Doblin. 

“By breaking down that barrier, we have opened the doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine and more,” Doblin wrote in a post to X, formerly known as Twitter. “The Novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”


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