Lysergic acid diethylamide

MindMed detailed promising Phase 2b results for its LSD treatment for generalized anxiety disorder as it presses on with three late-stage trials in the increasingly competitive field of psychedelic medicine. The company published data Thursday in JAMA, almost two years after first announcing that specific doses of the drug were successful at improving patients’ anxiety symptoms compared to placebo. The 100 µg dose that went into Phase 3 testing also showed a statistically significant improvement in patients’ depression symptoms, a secondary endpoint of the anxiety trial. MindMed now faces a question that all companies in the budding psychedelic field have to answer: How do you sell the drug? Less than half of the patients in the 100 µg dose arm of the Phase 3 study met the criteria to safely end the session after eight hours, but that jumped to 70% by hour nine. CEO Rob Barrow said in an interview that MindMed is not trying to fit LSD within the infrastructure and dosing period established by Johnson & Johnson and its blockbuster esketamine depression treatment. Spravato is administered in a two-hour dosing and evaluation period, twice a week for the first month of administration. That drops to one dose a week in the second month. “We don’t want to be,” he said. “This is different, and it’s different for many important reasons.” MindMed’s MM120 was administered as a one-time monotherapy, with follow-up continuing up to 12 weeks after dosing. Barrow and medical chief Dan Karlin hope that clinics administering their drug could be reimbursed based on time spent with the patient. “If you’re getting paid by the hour, and you can just fill up a room for a day with a patient and get paid for that entire day, that is extremely attractive to clinics as well, because then they don’t have to worry about turnover,” Barrow said. More than 90% of patients treated with 100 µg experienced visual perception changes, like hallucinating, and 40% reported nausea. One patient in the smaller 50 µg group experienced a panic attack 97 days after the dosing session that was deemed unrelated to the LSD, while one patient in the 100 µg group dropped out of the study due to adverse events. No patients engaged in self-harm or suicidal behavior during the trial, according to MindMed, and patients with a history of suicidal ideation who were in the trial did not report an increase in severity. Roughly 9% of the patients randomized to receive either LSD or placebo had to drop out for not following the protocol, which included taking prohibited drugs that could have affected MM120’s efficacy or safety. Karlin said patients who discontinued the trial due to protocol non-adherence did so because they experienced symptoms related to tapering off previously prescribed anxiety medications. “You see more of that in the less efficacious doses and in placebo,” he said. None of the patients in the 100 µg dose arm dropped out due to lack of protocol adherence. The first of two Phase 3 studies in generalized anxiety disorder is expected to read out in the first half of next year, with a second readout slated for the second half of 2026. A third Phase 3 trial in patients with major depressive disorder should have data in the second half of 2026. Patients in those trials will have the opportunity to receive up to four additional doses of 100 µg of MM120 over a 40-week open-label period if their anxiety or depression symptoms exceed certain thresholds. Karlin said this should simulate how people interact with the drug in the real world, where some experience a durable, single-dose effect, and others need some form of repeat dosing. “It’ll allow us to start to really provide some guidance for real-world use and what patients and physicians can expect from the drug,” he said.