FDA May Decide Today If MDMA Therapy For PTSD Will Be Approved
The decision will come after a decades-long campaign to legalize the psychedelic as a mainstream treatment — though the FDA could also put off a ruling if it needs to review clinical trial data. Among other news, magic mushroom use in palliative care, and the rise of legal psilocybin truffles.
Stat:
MDMA Therapy For PTSD Faces Imminent FDA Decision
A decades-long campaign to legalize MDMA as a mainstream medical treatment will reach a climax as soon as Friday, with the Food and Drug Administration poised to decide whether the psychedelic should be approved as a treatment for post-traumatic stress disorder in conjunction with psychotherapy. The regulators face an Aug. 11 deadline to decide whether to sign off on the drug or reject it. The agency could also postpone its decision if it needs more time to review data and investigate claims of irregularities in clinical trials run by Lykos Therapeutics. (Keshavan and Goldhill, 8/9)
In other news about psychedelic drugs —
The Guardian:
The End-Of-Life Patients Finding Solace In Magic Mushrooms: ‘What Life After Life Could Be Like’
Larger studies are under way to see if psilocybin could be a tool regularly used for palliative care, to ease the dying process. But researchers are still asking: how exactly does psilocybin help people confront their demise? (Love, 8/6)
The Times:
Are Legal Psilocybin Truffles The New Magic Mushrooms?
Two hours, one workout and an oat-milk iced coffee after his “breakfast of champions”, Mike Tommasiello feels it kicking in. “I can feel it start to course through my body,” he says. “I feel the energy. I feel the spark. All of a sudden, it’s like, everything becomes sort of very clear.” Every morning from Monday to Thursday, shortly before hitting the gym, Tommasiello, a 36-year-old advertising executive, takes a finely tuned cocktail of supplements, including ashwagandha and green tea extract. He also takes a dose of psilocybin, the active ingredient in hallucinogenic magic mushrooms. (Joyner, 8/9)
More FDA news —
NBC News:
FDA’s ‘Hands-Off Approach’ To Additives May Allow Unsafe Ingredients In Food, Experts Suggest
The Food and Drug Administration’s “hands-off approach” to food additives, including those found in ultraprocessed foods and energy drinks, may allow unsafe ingredients to enter the nation’s food supply, according to the authors of an editorial published Thursday. The paper, in the American Journal of Public Health, comes as lawmakers and public health groups allege that the FDA has failed to take quick action to protect the public from certain additives — including brominated vegetable oil and red dye No. 3 — in food products. (Lovelace Jr. and Fattah, 8/8)
