One LSD trip shown to provide rapid and lasting reduction in anxiety, FDA designates "breakthrough therapy"

The US Food and Drug Administration has granted a "breakthrough therapy" designation to a formulation of LSD shown to treat generalized anxiety disorder. The decision was based on clinical trials that showed the drug "exhibited rapid and robust efficacy" in reducing anxiety, "solidly sustained for 12 weeks after a single dose."

"A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it," said Tufts University School of Medicine psychiatrist Daniel Karlin who is chief medical officer for MindMed, the company developing the drug.

From CNN:

A single dose of MM120 (lysergide d-tartrate) led to a 48% rate of remission from generalized anxiety disorder at 12 weeks following the drug's administration, according to MindMed.

The MM120 drug also significantly improved clinical signs of generalized anxiety disorder for 65% of patients within three months, according to results of the phase 2b trial designed to test dosage levels, the company said…

"The clinical improvement for many patients was more than double what we see with today's standard of care," Karlin said. "This occurred at all levels of anxiety, from moderate all the way up to severe."