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Angermayer vs. Doblin: R-MDMA Race to Market and Clinical Trials

Should the FDA Reschedule Rick Doblin?

March 8, 2024 SXSW Austin, TX

Rick Doblin claims that there is a 95% chance that MDMA gets approved this August.

MAPS new phase 3 clinical trial do-over could cost twice the $20 million dollar average and take more than 3 years resulting in too small of a data set because of the Manualized Psychedelic Assisted Therapy component that makes the efficacy testing much more complex to measure with therapists involved.

I wonder if they will abandon the 50/50 (S-MDMA/R-MDMA) racemic mixture formulation for the R-MDMA only formulation when a study from 2019 said,

“these data suggest that R-MDMA could be a more viable therapeutic option for the treatment of PTSD and other disorders for which S/R-MDMA is currently being investigated” since “R-MDMA unlike racemic MDMA, did not increase locomotor activity, produce signs of neurotoxicity, or increase body temperature.

A key pharmacological difference between R-MDMA and racemic MDMA is that R-MDMA has much lower potency as a dopamine releaser. Together, these results indicate that the prosocial and therapeutic effects of S/R-MDMA may be SEPARABLE from the stimulant, thermogenic, and potential neurotoxic effects.”

Does this mean that the removal of the stimulant, thermogenic and potential neurotoxic effects means a therapist is not required and patients can take home R-MDMA for microdosing like is now happening in a clinical trial with take home LSD?

Might Christian Angermayer beat Rick Doblin to market with his R-MDMA? Will Rick Doblin have to abandon his ManPAT to beat Atai to market?

Angermayer says, “The trials of MAPS/Lykos have been deemed chaotic, with nonstandard designs – particularly regarding therapy – and questionable execution. IMO their Phase 3 trials more closely resemble traditional phase 2a trials in terms of size and quality.

New trials can overcome the shortcomings of this package and potentially result in ultimate approval.”

Even if the original / racemic MDMA does not recover from this setback (although I hope it does with more and better studies), atai has a new, potentially better and patent-protected version of MDMA in its pipeline (as we had foreseen the problems that now became obvious), which in early trials has demonstrated a much better initial safety profile.”

Separating the agony from ecstasy: R(−)-3,4-methylenedioxymethamphetamine has prosocial and therapeutic-like effects without signs of neurotoxicity in mice

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About Ian Benouis

Ian is a West Point graduate, former US Army officer, Blackhawk helicopter pilot and combat veteran. He is Patient Number One at the Mission Within which treats special operators with PTSD, TBI and addiction using iboga and toad (5-meo-dmt) in Mexico.  He is an advisor there, after being the General Counsel and spearheading the veteran healing program.  Ian has been helping wounded veterans for over 9 years. Ian has moderated numerous veteran’s panels including the MAPS Psychedelic Science conference in 2018 in Austin and the World Bufo Alvarius Congress in 2019 in Mexico City. He founded an ONAC church chapter which was later returned to the parent church.  He is a founder of a Santo Daime church which is the US chapter of a Brazilian government approved church and between himself and his law partner Greg Lake, have created over sixty entheogenic churches in the US. Ian participated in Operation Just Cause in the Republic of Panama.  This operation was the largest combat operation in US history focused directly on the War on Drugs and was the largest special operations deployment ever conducted. He was a pilot-in-command and his aviation brigade flew more night vision goggle hours than any unit in the military except for the Task Force 160 Special Operations which his unit was ultimately rolled up into when the 7th Infantry Division at Fort Ord, California military base was shut down. Ian grew up in Hawaii in the 1970’s where cannabis and mushrooms were decriminalized and integrated into the culture.  He has been healing himself for over 30 years with sacred medicines, a spiritual practice, and being a student and practitioner of ethnobotany. Ian was a pharmaceutical representative for Pfizer after he got out of the Army witnessing firsthand the rise of the SSRI’s and synthetic opioids in the early 1990’s. He is a casualty of the drug war having been arrested for cannabis while in law school.  Ian is an intellectual property attorney who worked in the corporate world for over 20 years in the primary roles of VP of Sales and Marketing and General Counsel. He is a political activist in the cannabis and entheogenic medicine space nationally and locally in Texas.  Ian was previously the Chairman of the Board for a public policy foundation in Texas for over 7 years. Ian was featured in the Spike Jonze produced episode Stoned Vets on Weediquette the cannabis focused series on Viceland on HBO with a number of other veterans protesting the VA’s policy on medical cannabis and working to end the veteran suicide epidemic. In 2016 Ian organized a trip for six veterans with PTSD to Peru in May for a 10-day plant diet including ayahuasca and other plant medicines with three Shipibo trained shaman brothers.  Ian also took some of the same veterans to Mexico for treatment with iboga and 5-Meo-DMT.  This experience was captured on video and was released as a documentary in March 2017 entitled Soldiers of the Vine. He is member of the team that created the movie From Shock to Awe a feature-length documentary that chronicled the journeys of military veterans as they sought relief from PTSD with the help of ayahuasca and MDMA. Ian is a Co-Founder of the Church of the Sacred Synthesis which offers the sacrament psilomethoxin and he is the first human being to ingest it through bioassay.