An FDA advisory panel voted against the approval of Lykos Therapeutics' midomafetamine (MDMA) capsules used in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD), on the grounds of both efficacy and risk benefit.
When asked whether the available data show that MDMA is effective in patients with PTSD, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted 2-9 against the treatment. The panel then voted 1-10 against on the question of whether the benefits of MDMA with FDA's proposed risk evaluation and and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD.
The panel's review included results from two randomized, double-blind, placebo-controlled phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo with psychological intervention in participants diagnosed with severe or moderate to severe PTSD. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints.
But questions have been raised prior to the AdComm meeting about the those trials.
In March, the nonproft group, Institute for Clinical and Economic Review (ICER), published a report that highlighted placebo bias and ethical issues in Lykos’ data. "Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms," said ICER in its report.
Why Lykos has remained relatively quiet on a matter, a group of investigators involved in the trial did refute the accusations made in the ICER report.
Lykos, formerly known as MAPS Public Benefit Corporation, says it's committed to working with the FDA to get approval for it MDMA-assisted therapy. The treatment currently has a PDUFA target action date of August 11, 2024.
