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A clinical trial’s encouraging results won US Food and Drug Administration breakthrough therapy status for an LSD formulation to treat generalized anxiety disorder, Mind Medicine Inc. announced Thursday. The biopharmaceutical company is developing the drug.
“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 Dr. Daniel Karlin, assistant professor of psychiatry at Tufts University School of Medicine in Boston and chief medical officer for MindMed.
MindMed’s MM120 will still go through the standard FDA approval process, including phase III trials.
The designation, however, “is an offer from the agency to engage more closely in drug development,” Karlin said. “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.”
Two other companies have also received FDA breakthrough therapy status: psilocybin for treatment-resistant depression and to MDMA, (3,4-Methylenedioxymethamphetamine) commonly known as ecstasy or molly, for post-traumatic stress disorder or PTSD.
New results on efficacy at 12 weeks
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.
Anxiety is the most common mental disorder in the United States, affecting over 40 million people age 18 and older each year, according to the Anxiety and Depression Association of America. Generalized anxiety order is characterized by excessive, ongoing thoughts that are difficult to control and interfere with day-to-day activities.
“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.”
Standard of care for generalized anxiety disorder is a combination of cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors, or SSRIs, and buspirone — both of which work on levels of serotonin in the brain — as well as sedatives called benzodiazepines…
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