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.
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.
