MDMA’s efficacy data likely to support FDA approval after studies did not lead to drug abuse, says GlobalData

Following the publication of a new study of the long-term effectiveness of midomafetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD);

Philippa Salter, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“New long-term data for MDMA as a treatment for PTSD adds to the evidence of the effectiveness of the drug and should help it gain approval when Phase III trials have been completed. The demonstration that, in combination with psychotherapy, the drug does not lead to patients abusing MDMA or other drugs will increase the FDA’s confidence in the safety of the drug and increase its likelihood of approval. This will allow MDMA to gain a competitive advantage against its competitors and contributed to GlobalData’s estimate that, by 2028, MDMA will see a total annual revenue of $326.6m in the US and 5EU.

“Currently, drugs with antidepressant, anticonvulsant and anxiolytic properties are typically prescribed for PTSD, with varying outcomes for each patient. One urgent issue that needs to be addressed is the increase in suicidal behaviors as a side effect of antidepressants. This is of particular concern for PTSD patients, as PTSD has a high rate of suicide compared with other mental illnesses. The long-term study also showed that there was a reduction in suicidal thoughts in patients with midomafetamine treatment, which should give midoafetamine a strong competitive edge in the market and makes it one of the most promising agents in the pipeline for PTSD.”

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