Psychedelic Medicine Has a Therapy Problem

The US FDA has declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD), citing missing data on adverse events and misconduct complaints. The FDA asked the company to undertake further clinical trials to ensure the treatment’s safety and effectiveness. This decision may impact how therapy and drug combinations are viewed and regulated, even so, Lykos Therapeutics plans to request that the FDA reconsider its decision.