With MAPS moving its historic Phase 3 MDMA trial towards FDA approval, the movement toward psychedelic legalization is gaining increasing momentum. The forthcoming FDA approval of MDMA will be a milestone that will likely accelerate the path towards legal psychedelics.
But which psychedelics will be next to be FDA approved? We take a closer look.
MAPS and MDMA for PTSD
We’ll start here because this is the industry’s most advanced clinical trial and likely next psychedelic to be FDA appproved.
The first Phase 3 results by MAPS sent positive waves throughout the industry and helped reinforce the thesis among investors and medical professionals: 67% of patients treated with MDMA-assisted therapy no longer met the official criteria for having PTSD; while 88% of patients saw their symptoms decrease by 50% or more. Amazing stuff for a Phase 3 trial.
According to MAPS, the second, confirmatory Phase 3 trial is completed with positive results expected to be released soon and FDA approval in 2024. See an updated timeline below.
When will #MDMA therapy actually be commercialised? End of 2024 seems the time.
Latest plans from @MAPS plan to release data from Phase 3 in the next 3 months, and submit to the FDA by the end of 2023. FDA approval is expected by half of 2024, and first patients end of 2024. pic.twitter.com/9mWU7aj2L8
— Tommaso Barba (@tommaso_barba) June 21, 2023
Compass Pathways Phase 3 Trial: Psilocybin for Treatment-Resistant Depression
Compass received FDA Breakthrough Therapy designation in 2018 for their COMP360 psilocybin compound. In late 2021, the firm completed the world’s largest psilocybin study to date, a double-blind phase 2b study of COMP360 psilocybin therapy in 233 patients with Treatment-Resistant Depression (TRD) in 22 sites across Europe and North America. The Phase 2b results were solid, but not as revolutionary as MAPS’ trial.
Compass is now rolling out its big Phase 3 trial, which will be done in two part. See details here. This trial is the most advanced psychedelic study with the FDA after MAPS’ and if all goes well, Compass’ COMP360 psilocybin compound would be the next psychedelic approved by the FDA (still at least 2-3 years away).
MindMed Phase 2b Trial: LSD for Anxiety
MindMed’s Phase 2b using LSD for Generalized Anxiety Disorder is the next most advanced trial making its way towards FDA approval of psychedelics.
The trial plans to enroll up to 200 participants who will receive a single administration of its MM-120 LSD or a placebo. Topline results are expected to be announced in late 2023 and 50% of participants have already been enrolled.
In May 2022, MindMed collaborators at the Liechti Lab and the University Hospital Basel announced topline data from their Phase 2 trial using LSD for anxiety. The results demonstrated significant and beneficial effects of LSD to safely mitigate symptoms of anxiety and depression.
These positive results will support MindMed’s LSD program as it makes its way through FDA approval, and also gives hope that the upcoming Phase 2b trial will be successful for both the company and patients. Generalized Anxiety Disorder is a serious condition affecting millions of people worldwide.
Awakn Life Sciences’ Phase 3 Trial: Ketamine Therapy for Alcohol Use Disorder
Awakn Life Sciences has announced that its Phase 3 trial using ketamine for Alcohol Use Disorder is going ahead in several sites across the UK.
Earlier this year, Awakn Life Sciences announced impressive results from its Phase 2 trial using ketamine for Alcohol Use Disorder – including 86% abstinence 6 months after treatment with no serious side effects. Very impressive results.
This Phase III clinical trial will explore the use of ketamine-assisted therapy for the treatment of severe AUD will be delivered across seven NHS sites in the UK. The trial has also been approved for grant funding for 66% of the costs by the National Institute for Health and Care Research (NIHR), a UK government agency.
With ketamine already being an approved substance, and with the trial receiving government support, this trial has a high likelihood of regulatory approval.
