A new FDA report casts doubts on what could become the first psychedelic-based treatment approved in the U.S.
to treat PTSD, citing the potential for abuse and possible harmful side effects to the heart and liver.The findings cast new doubts on what could become the first psychedelic-based treatment approved in the U.S. ahead of a June 4 meeting during which FDA advisers will review a new drug application from Lykos Therapeutics.Clinical trials using MDMA to treat PTSD made it difficult to assess safety and effectiveness, FDA staff wrote.
The small sample sizes in Phase 1 and 2 studies also made it difficult to confirm the treatment would not cause liver damage observed in earlier studies of illicit use of the drug, the report states. The FDA report notes Lykos' application includes evidence patients who received the drug experienced "statistically significant and clinically meaningful improvement" in their PTSD symptoms, and that improvement appears to last for at least several months.
Post-Traumatic Stress Disorder (PTSD) Medical Research Clinical Trials Psychedelics
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