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FDA Expected to Approve MDMA Therapy for PTSD Following Latest Trial

A therapy using the drug MDMA for post-traumatic stress disorder (PTSD) is likely to be approved by US regulators in the next year. This follows the results of the largest clinical trial to date, which found that MDMA therapy was safe and effective in a diverse group of participants.

PTSD affects an estimated 3.9 per cent of people worldwide at some point in their lives. Currently, the only approved pharmaceutical drugs to treat the condition in the US are antidepressants.

Previous studies have explored the use of MDMA, commonly known as ecstasy, in psychotherapy for individuals with PTSD. The drug helps patients enter a more relaxed and trusting state, dampens fearful responses when recalling past trauma, and enables them to engage more openly with therapists.

The latest trial involved 104 people from the US and Israel who were diagnosed with moderate to severe PTSD. The study showed that 71.2 per cent of the group receiving MDMA therapy no longer met the diagnostic criteria for PTSD, compared to 47.6 per cent of the placebo group. These results indicate that MDMA therapy can be effective and offer hope for a wider population.

In 2017, the US Food and Drug Administration (FDA) granted MDMA-assisted psychotherapy a “breakthrough therapy” designation, allowing the treatment to move forward in the approval process. With the positive outcomes of the latest trial, FDA approval for MDMA therapy for PTSD could be granted as early as next year.

This development is seen as a significant step forward in providing a new and potentially life-changing treatment option for individuals with PTSD.

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