Comment on NDA for Lykos' MDMA from Dr. Marion Coe

Marion Coe, Director, Clinical Development and Postmarketing Surveillance at Pinney Associates

I support approval of midomafetamine (MDMA) capsules for the treatment of posttraumatic stress disorder (PTSD). This medication assisted therapy holds significant potential for public health benefit by providing an effective treatment for PTSD, a condition affecting millions of people. It is likely to contribute to a decrease in PTSDrelated suicides and homelessness, offering substantial societal benefits. Its approval could also reduce the burden on healthcare systems by lowering associated costs and improving patients’ quality of life.

The risks of MDMA administration have been effectively managed in the Lykos clinical trials, and adhering to these same therapeutic conditions after approval should mitigate potential risks in the real world. Nonetheless, MDMA does pose potential serious safety concerns that can and should be addressed by a risk evaluation and mitigation strategy (REMS) program which goes beyond labeling to address serious safety concerns.

Read Dr. Coe’s full comment here.