FDA Authorizes LaNeo MDMA to Target Schizophrenia in Clinical Trials

Schizophrenia is a mental illness that brings psychosis and often hinders one's ability to live an average daily life. On June 9, PharmAla Biotech announced that the FDA had authorized using LaNeo MDMA Investigational Medical Product (IMP) capsules (40mg) in a UCLA clinical trial for targeting the illness.

In a limited group of individuals with schizophrenia, the tolerance of the MDMA IMP, created by the Canadian biotech company PharmAla, will be evaluated.

Many symptoms of schizophrenia, such as hallucinations and delusions, are managed by antipsychotic drugs, but asociality is often difficult to treat.

According to research, MDMA, which is well-known for its pro-social properties, may be able to treat these asocial symptoms, such as removing oneself from social activities or losing interest in hygiene.

Healthy test subjects who receive MDMA report feeling more compelled to interact socially and experiencing feelings of closeness and empathy; this is thought to be partially due to how the medication impacts oxytocin, also referred to as the "love hormone."

Many people have become more interested in psychedelic substances like psilocybin, ketamine, and MDMA due to their potential to cure mental conditions like post-traumatic stress disorder, major depressive disorder, and schizophrenia.

Following the FDA's certification of MDMA as a "breakthrough therapy" in 2017, this trial is yet another in a series of experiments to examine its potential therapeutic value. With the FDA's approval, PharmAla's clinical-grade MDMA IMP is now eligible for use in American trials where it will be tested on patients with schizophrenia.

Clinicaltrials.gov reports that the trial has been given the go-ahead to evaluate the tolerability of the IMP, also known as LaNeoTM MDMA, in 40mg capsule form. The open-label study is anticipated to enroll only 20 individuals with schizophrenia and will be finished in March 2026.

The participants will get three increasing doses of MDMA from the researchers — 40mg, 80mg, and 120mg. The acceptability of these doses will be evaluated 24 hours after dosing using the PANSS scale (positive and negative syndromic scale for schizophrenia), which ranks the severity of disorganized speech, delusions, and hallucinations on a scale from one to seven.

"We found that the FDA scrutinized our materials and processes in a rigorous but fair fashion," continues the founder and CEO of PharmAla Nicholas Kadysh.

"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."

Choosing a maximum well-tolerated dose for the subsequent study will be made more straightforward, and future studies on MDMA and other psychedelic drugs for treating challenging symptoms of schizophrenia may be built on the study's findings.

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.

- Vice president of research at PharmAla, Harpreet Kaur

Kaur concludes that, as with any IMP source, there are always concerns regarding chemistry, manufacturing, and control, even for well-known compounds. She says the announcement should prove that the IMP satisfies the exacting standards of one of the world's top regulators regarding quality and documentation.

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