The Food and Drug Administration declined Friday to approve an application to treat post-traumatic stress disorder using the drug midomafetamine, also known as MDMA or the street drug ecstasy, citing "significant limitations" with the data submitted to the agency. Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD . Lykos said the FDA asked for another phase 3 trial to study the safety and efficacy of MDMA.
"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," Amy Emerson, the CEO of Lykos Therapeutics, said in a release . Emerson said that conducting another phase 3 study, as requested by the FDA, "would take several years" to be done. Phase 3 trials are typically the final and largest stages of clinical studies that drugmakers conduct before seeking approval.
Lykos acknowledged that the concerns the FDA raised echoed those that were brought up by an advisory committee earlier this year. That panel had voted by a majority against the application over a number of concerns about the trials it had done so far. The company says it plans to eventually seek resubmission, as it works "diligently in the coming months to addres.