Update on FDA Advisory Committee Meeting for investigational MDMA-assisted therapy for PTSD
Lykos Therapeutics), announced the outcome of the 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 August 11, 2024.
PDAC's review included results from two randomized, double-blind, placebo-controlled Phase III studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider, versus placebo with psychological intervention in participants diagnosed with severe or moderate to severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine ( previously cited).
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