Biopharma firm Mind Medicine announced that they have dosed the first-ever patient in a Phase 3 clinical trial of LSD. The individual tripped on lysergide D-tartrate, an LSD formulation for which the US FDA granted "breakthrough therapy" status in March as a promising treatment for generalized anxiety disorder (GAD).
Of course, Mind Medicine has patented this particular LSD formulation. Named MM120 ODT, they claim the drug is "pharmaceutically optimized," promising "a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects."
Anyway, LSD now joins MDMA and psilocybin in that category of drugs that treat "a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies."
MindMed expects to enroll 200 participants in the study, called Voyage.
"MindMed's Phase 2b study, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A)at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort," the company states in a press release. "MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug."
Previously:
• Ancient psychedelic wisdom for modern medicine
• Netflix's 4-part adaptation of Michael Pollan's book on psychedelics, 'How to Change Your Mind'
• FDA denies approval of MDMA-assisted therapy for PTSD
• MDMA can help treat PTSD, yet another study shows
