The United States Food and Drug Administration has granted “breakthrough therapy” designation to LSD after a clinical trial found it to be beneficial in treating generalized anxiety disorder.
Someone using a tweezer to grab a microdose of LSD (photo credit: Microgen/Shutterstock).
The clinical trials found that LSD “exhibited rapid and robust efficacy” in combatting anxiety, which was “solidly sustained for 12 weeks after a single dose.”
Daniel Karlin, a psychiatrisy at Tufts University School of Medicine, says “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.”
Karlin says the designation “is an offer from the agency to engage more closely in drug development. It affects timelines of response and our ability to get more interactions with the agency so that we can be sure that we’re in lockstep agreement as we move forward.”
In the clinical trial, a single dose of MM120 (lysergide d-tartrate) led to a 48% rate of remission from generalized anxiety disorder at 12 weeks. LSD also significantly improved clinical signs of generalized anxiety disorder for 65% of patients within three months.
“The clinical improvement for many patients was more than double what we see with today’s standard of care,” said Karlin. “This occurred at all levels of anxiety, from moderate all the way up to severe.”
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