The Multidisciplinary Association for Psychedelic Studies (MAPS) is developing the first-in-class innovator drug midomafetamine (MDMA) for use in treating chronic and delayed-onset post-traumatic stress disorder (PTSD). The drug is currently in Phase III development in the US and Europe. Following positive Phase II trial data showing that midoafetamine resulted in a significant reduction in PTSD symptoms, the FDA granted it Breakthrough Therapy Designation in 2017. Further results continue to demonstrate its effectiveness for treating PTSD.
A new study compiling data from six previous trials and looking at the long-term outcomes of midomafetamine treatment found that continued improvements in most patients for more than one year after the treatment ended. The follow-up data showed that 67% of patients no longer met the clinical criteria that would lead to a diagnosis of PTSD more than one year after treatment ended, compared with 56% of patients at the original endpoint of the trials used in this study. This new long-term data add to the evidence of the effectiveness of midomafetamine for treating PTSD and should help the drug gain approval when the Phase III trials have been completed. GlobalData expects midomafetamine to launch in the US in 2021 and in Europe in 2022. By 2028, GlobalData forecasts total annual revenue of $326.6M for midomafetamine in the US and Europe.
In the US, MDMA is classified as a Schedule I drug, meaning that it has a high potential for abuse. However, this study found that MDMA in combination with psychotherapy does not lead to patients abusing MDMA or other drugs. This is important data that will increase FDA confidence in the safety of the drug, which will, in turn, increase its likelihood of approval.
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 behaviours as a side effect of antidepressants such as Pfizer’s Zoloft (sertraline) and GlaxoSmithKline’s Paxil (paroxetine). 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.