FDA Advisory Panel Weighing Use Of Psychedelic Drug MDMA To Treat PTSD
Stat will offer live updates on committee action to determine whether the drug has therapeutic uses.
Stat:
Tracking The FDA Advisory Panel On MDMA Therapy For PTSD
MDMA is the first Schedule I psychedelic to be considered by the FDA — meaning that, if it’s approved, it would no longer meet the Drug Enforcement Administration’s Schedule I definition of having “no medical benefit.” After years of excitement and conversation about the potential for psychedelics to treat mental illness, this is a huge moment for the field and the burgeoning multibillion-dollar psychedelics industry. The discussion will start at 8:30 a.m. ET and run until about 5:30 p.m. (Goldhill and Keshavan, 6/4)
The Mercury News:
MDMA Therapy, Conceived In The Bay Area, Gets First Regulatory Test -- And Commercialization
Rick Doblin first dreamed of the therapeutic potential of the psychedelic drug MDMA in a hippie house in downtown Santa Cruz, in an era when fears of bad trips and ruined lives loomed large in the public imagination. On Tuesday, 38 years later, his vision will go before a U.S. Food and Drug Administration’s advisory committee of medical experts who will make a recommendation about whether the drug, when combined with talk therapy, should be a legal part of modern medicine. (Krieger, 6/3)
High Times:
Claims Of Misconduct Mar MDMA Research For PTSD
The report notes that it is not easy to conduct research into psychedelics because it is difficult to obscure which participants are receiving a placebo and which are receiving the active drug because of the unmistakable effects of psychoactive drugs. As a result, most of the study subjects correctly guessed which group they were in, according to a review of the research released by the FDA on Friday. Without proper blinding, the findings can be skewed by participants or researchers, many of whom see strong promise in the therapeutic potential of the compounds. (Herrington, 6/4)
In related news —
Bloomberg:
Magic Mushrooms Get Export License From Canada In Psychedelic Race To Market
Canada has licensed a startup to export psychedelics to Australia for patient use, the latest milestone in a contest to supply the potential growth of medical psychedelic drugs. Canada’s health department awarded a drug establishment license to Optimi Health Corp., a spokeswoman for the company said, allowing it to ship pills containing the magic-mushroom extract psilocybin and MDMA — controlled and otherwise-illegal substances — to a provider in Australia. (Seal, 6/3)
