, /PRNewswire/ -- ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new drug application ("NDA") for midomafetamine (MDMA) capsules used in combination with psychological intervention ("MDMA-assisted therapy") for the treatment of post-traumatic stress disorder ("PTSD") in adults.
PDAC voted 2 yes to 9 no on the question of whether the available data show that midomafetamine is effective in patients with PTSD. They also voted 1 yes to 10 no on the question of whether the benefits of midomafetamine with FDA's proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD. The FDA is not bound by PDAC's guidance but takes its advice into consideration.
The role of PDAC is to provide the FDA with independent, expert advice and recommendations based on their review and evaluation of data concerning the safety and effectiveness of investigational medicines for use in the practice of psychiatry and related fields. The FDA's approval decision is expected by the Prescription Drug User Fee Act ("PDUFA") target action date of . "We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psych.
