Comment on NDA for Lykos' MDMA from Dr. Jack Henningfield

Jack Henningfield, Vice President, Research Health Policy and Abuse Liability, Pinney Associates.

I support the approval of MDMA for the treatment of post-traumatic stress disorder (PTSD). Phase 2 and 3 studies have demonstrated efficacy and, equally importantly, the studies have shown that it can be used safely under various conditions and approaches to therapeutic use that have been employed. These findings provide a foundation for labeling and risk evaluation and mitigation strategies, referred to as REMS, as well as elements to ensure safe use (ETASU) that should be considered in the Food and Drug Administration’s (FDA’s) benefit-risk evaluation for approval decisions.

MDMA is a Schedule I substance under the Controlled Substances Act. Approval of an MDMA drug product for therapeutic use by FDA would necessitate rescheduling to one of the four CSA schedules reserved for drug products that are approved by FDA for therapeutic use or otherwise determined to meet criteria for commonly accepted medical use (see discussion of such regulatory issues by Henningfield, Coe, Griffiths et al. 2023). We hope that FDA’s rescheduling recommendations will avoid unnecessarily restrictive scheduling and/or burdensome REMS requirements, which could hinder access to those who could benefit from the potentially life-saving benefits of this medication assisted therapy. Such barriers can contribute to exacerbating already existing health disparities related to ethnic/racial factors, geographic location, and economic means.

As I have testified at other FDA meetings, I recommend that all policies, including CSA scheduling and REMS, should take into account the potential impacts on disparities in healthcare access. In this regard, Advisory Committee members, FDA, and other stakeholders might take into consideration the peer reviewed Neuropharmacology commentary in a special issue addressing psychedelics that addressed policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines (Belouin, Averill, Henningfield, et al., 2023; Also see Yaden, Griffiths & Potash, 2023; Yaden, Yaden & Griffiths, 2021).

Read Dr. Henningfield’s full comment here.