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MDMA Approved for Schizophrenia Clinical Trial by FDA

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The U.S. Food and Drug Administration (FDA) has approved the use of 3,4-methyl​enedioxy​methamphetamine – better known as MDMA – for use in a small clinical trial conducted by the University of California, Los Angeles (UCLA). The tolerability of the MDMA investigational medical product (IMP), produced by Canadian biotech PharmAla, will be assessed in a small number of patients with schizophrenia.

Targeting difficult-to-treat schizophrenia symptoms

Schizophrenia is characterized by hallucinations, delusions and disorganized thinking, as well as asocial symptoms such as losing interest in everyday activities, lack of interest in personal hygiene and avoidance of people. Antipsychotic medications treat many of the symptoms of schizophrenia, although there are no treatments for asociality.

Research suggests that MDMA, known for its pro-social effects, could potentially tackle these asocial symptoms. The drug increases motivation for social engagement and can produce feelings of empathy and closeness among healthy volunteers – this is thought to be in part due to its effects on oxytocin, the “love hormone”.

Interest in psychedelic compounds such as psilocybin, ketamine and MDMA has been increasing, with many drawn by their potential for the treatment of psychiatric disorders such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD) and schizophrenia.

In 2021, a Phase 3 clinical trial from the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) showed that participants with PTSD who received both MDMA treatment and psychotherapy were twice as likely to recover compared to those who received a placebo and psychotherapy.

This is yet another in a string of trials to evaluate the potential therapeutic efficacy of MDMA after its designation by the FDA as a “breakthrough therapy” in 2017. Now, the green light from the FDA for PharmAla’s clinical-grade MDMA IMP marks its first approval for trial use in the United States and will be evaluated in patients with schizophrenia.

Approved for use in clinical trial

According to clinicaltrials.gov, the trial (NCT05770375) has been approved to assess the tolerability of the IMP, known as LaNeo™ MDMA, in 40 mg capsules. The open-label study is estimated to enroll a small number of participants – 20 patients with schizophrenia – and has an estimated completion date of March 2026.

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The investigators plan to administer to the participants 3 separate ascending doses of 40 mg, 80 mg and 120 mg MDMA. The tolerability of these doses will be measured by clinician-rated psychotic symptoms 24 hours after dosing using the PANSS scale (positive and negative syndromic scale for schizophrenia) to measure disorganized speech, delusions and hallucinations on a scale from 1 to 7 based on their severity. This will help to select a maximum well-tolerated dose for use in future studies.

The study’s findings have the potential to lay the groundwork for additional studies of MDMA and other psychedelic compounds for difficult-to-treat symptoms in schizophrenia.

“We found that the FDA scrutinized our materials and processes in a rigorous but fair fashion,” said Nicholas Kadysh, founder and CEO of PharmAla. “As with all of our clients, we worked hard to support UCLA researchers in their application to [the FDA]. We hope that they are pleased with the results, and look forward to providing them with their IMP as soon as [the Drug Enforcement Administration (DEA)] and Health Canada issue the relevant permits.”

“While we’ve had great success with many regulators around the world, it’s still a major milestone to receive a stamp of approval from [the FDA] for our investigational drugs,” said Dr. Harpreet Kaur, vice president of research at PharmAla. “As with any IMP supplier, there are always questions about chemistry, manufacturing and control – even for well-known molecules. We believe that this announcement should confirm that our IMP conforms to the high levels of quality and documentation that one of the pre-eminent regulators in the world requires.”

This article is a rework of a press release issued by PharmAla Biotech. Material has been edited for length and content.