FDA Declines Approval Of MDMA-Assisted Therapy For PTSD Treatment

It is currently a Schedule I drug, meaning it is considered to be highly dangerous with no accepted medical use.

The FDA has declined to approve MDMA-assisted therapy in the treatment of PTSD.

Drugmaker Lykos Therapeutics recently requested for MDMA to be used. The drug is commonly known as ‘molly’ or ‘ecstasy.’ It is technically an amphetamine but is often categorized as a psychedelic.

It is currently a Schedule I drug, meaning it is considered to be highly dangerous with no accepted medical use. However, a number of clinical trials have displayed the benefits that come from the use of MDMA in combination with talk therapy for patients suffering from PTSD.

The FDA granted “breakthrough therapy” status to MDMA-assisted therapy in 2017, but has now declined to approve the company’s application for the use. It was decided the benefits did not outweigh the risks, including increased blood pressure and abuse potential.

The agency requested an additional Phase III study which is the stage in which clinical trials compare to standard treatment versus what is being offered.