March 7 (UPI) — A psychedelic medicine biotech company announced Thursday its LSD-based drug has won U.S. Food and Drug Administration breakthrough treatment status for treating generalized anxiety disorder with lasting relief.
“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, chief medical officer of Mind Medicine Inc., also known as MindMed.
The medication, MM120, still has to go through the FDA’s standard approval process, which will include Phase III trials.
“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” said Dr. David Feifel, an investigator in the MM120 study.
MindMed shares rose 58% on the FDA news Thursday.
MindMed said in a statement it intends to have “an End-of-Phase 2 meeting with the FDA in the first half of 2024 and initiate a Phase 3 clinical program in the second half of 2024.”
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” said MindMed CEO Robert Barrow in a statement.
The company said in that Phase 2b study, MM120 was generally well-tolerated with mild to moderate “adverse events” that were transient and occurred on dosing day.
The most common of the adverse events happened among at least 10% of high dose groups and included “illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.”
The data will be presented May 4-8 at the American Psychiatric Association’s annual meeting in New York.
