FDA rejects MDMA for treating PTSD, calls for redo of study, drugmaker says
SUMMARY
The FDA rejected Lykos Therapeutics' application to use MDMA, also known as ecstasy, for treating PTSD, citing significant data limitations and requesting another phase 3 trial. Lykos expressed deep disappointment, especially for the millions of Americans with PTSD, including many veterans, who have not seen new treatment options in over two decades. The rejection followed concerns raised by an advisory committee, including trial misconduct and difficulties in maintaining placebo controls. Veterans groups and lawmakers had urged the FDA to approve the drug, highlighting its potential for PTSD treatment. Despite the setback, Lykos plans to address the FDA’s concerns and resubmit. The potential of MDMA in treating PTSD, particularly for veterans, remains a topic of intense debate.
