MDMA Drug for PTSD Panned by FDA Advisers Citing Trial Flaws (1)

The psychedelic drug MDMA failed to get backing from US regulatory advisers to treat a form of mental illness, a setback to patients and advocates pushing for better treatment options.

Advisers to the Food and Drug Administration voted 9 to 2 that developer Lykos Therapeutics Inc.’s data failed to show the drug is effective in patients with post-traumatic stress disorder. The panel also voted 10-1 that a safety program wouldn’t be sufficient to protect patients from potential risks of the therapy.

The FDA will spend the next several weeks deciding whether to grant clearance for the medication before ...