(MedPage Today) – The FDA declined to approve midomafetamine (MDMA) capsules for post-traumatic stress disorder (PTSD), calling for another trial to evaluate the drug’s efficacy and safety, developer Lykos Therapeutics announced on Friday.

Lykos said the agency determined that the investigational psychedelic “could not be approved based on data submitted to date” and requested another phase III trial. The company plans to ask FDA to reconsider. (Read More)