FDA panel rejects use of MDMA to treat PTSD
An independent advisory panel to the Food and Drug Administration on Tuesday rejected the use of MDMA-assisted therapy for post-traumatic stress disorder, highlighting the unprecedented regulatory challenges of a new therapy using the drug commonly known as Ecstasy.Before the vote, committee members expressed concerns about the design of the two studies submitted by the drug's sponsor, Lykos Therapeutics. Many questions focused on whether study participants were generally able to correctly guess whether they had taken MDMA, also known as Ecstasy or Molly. The jury voted 9-2 on the effectiveness of MDMA-assisted therapy and 10-1 on whether the benefits of the proposed treatment outweighed the risks.Other speakers expressed concerns about the drug's potential cardiovascular effects...