FDA okays MDMA for therapists in Phase 1 PTSD trial
The Food and Drug Administration has authorized therapists who are being trained to deliver psychedelic treatments to participate in a Phase 1 trial studying MDMA therapy for PTSD, writes Marijuana Moment.
The MAPS MDMA-assisted therapy for therapists Phase 1 trial is:
- Designed to measure self-compassion, quality of life, and burnout among therapists delivering treatment
- Giving therapists personal experience with MDMA
- Aligned with the goals of MDMA Therapy Training Program
How it happened:
- MAPS asked for permission in 2019, The FDA questioned the merits of the research and put them on a 20-month hold until granting approval last week after MAPS appealed.
- Canadian regulators greenlit similar uses a few months ago
The study is complementary to the Phase 3 trials studying MDMA for PTSD by MAPS, which is expected to wrap up in 2023.
Updates on studies looking at ketamine and psilocybin for major depression, DMT for stroke rehab
Seelos Therapeutics (NASDAQ:SEEL) reported positive topline results from its latest study looking at ketamine for Major Depressive Disorder, with more than 76% of patients experiencing a reduction in symptoms after one dose, and sustained reduction in suicidality.
Cybin (NEO:CYBN) was approved by the University of the West Indies Hospital in Jamaica to start studying its sublingual psilocybin formulation in a Phase 2 clinical trial for people with Major Depressive Disorder.
Algernon Pharmaceuticals (CSE: AGN) says it received positive feedback from the FDA about its plans to research DMT’s potential to help people who have had a stroke to rehabilitate.
Field Trip appoints former US Senate Majority Leader Tom Daschle as a special adviser
Toronto’s Field Trip (CSE: FTRP) has brought Sen. Tom Daschle, one of the longest-serving Senate Democratic leaders in history, on board as a special adviser to the company. CEO Joseph del Moral said the company will benefit from three decades of experience working on public policy.
Why he’s joining: The South Dakota native said the global mental health crisis — made worse by Covid-19 — means there’s a “urgent need” for psychedelic assisted therapy.
“There is a paradigm shift underway in our understanding about the role that psychedelics can play in the field of mental health and well-being,” he said, “being primarily driven by scientists that are dedicating their time and energy to studying and understanding these molecules.”
Sen. Daschle will receive a stipend and options consistent with what members of the board receive.
Deepak Chopra partners with MindMed to bring awareness to psychedelic healing potential
New age and self-help guru Deepak Chopra will work with MindMed (NEO: MMED) to educate the public about the healing potential of psychedelics.
“I don’t believe psychedelics are a panacea, but I think they have a big role…with PTSD, in mental distress depression, suicide prevention and much, much more,” he told CNBC’s The News with Shepard Smith, who noted it wasn’t the first time the guru had promoted an alternative medicine and was criticized by people like evolutionary biologist Richard Dawkins.
“You just have to look up,” Chopra responded, just Google the evidence on mindfulness and mindful awareness on psychedelics, and ignore people like Dawkins.”
MindMed has also hired Peter Mack, PhD, to be VP of pharmaceutical development, who will lead all investigational drug development, partnerships with manufacturers and other discovery efforts.
Report Readout
Psychedelics are having a moment in Texas
Bloomberg: Psychedelics will follow pot’s path to legalization
The debate continues over psychedelics in California
Lexpert’s guide to psychedelic legalization in Canada
What’s in store for psychedelic science at Imperial College
Tensions continue between decrim advocates and indigeneous groups
The FDA approves PharmaTher’s (CSE: PHRM) IND application.
Wired: The case for treating trauma with MDMA.
