This year in March in the USA, the FDA has given ‘breakthrough status’ to an LSD-based treatment (MM120 or lysergide-d-tartrate) in phase 2b trials for generalised anxiety disorder (GAD). This has meant the clinical stage biopharmaceutical company MindMed has concluded phase 2 studies with the phase 3 studies development strategy being agreed with the FDA.^3,23,24

Studies had found clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo after 4 weeks, and 48% remission at 12 weeks. The drug had been given as a single 100 microgrammes dose in a monitored clinical setting with no additional therapeutic intervention.²³

The most common adverse events (at least 10% incidence in the high dose groups) on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paraesthesia (‘pins and needles’), dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis (dilated pupils) and hyperhidrosis.