Psychedelic therapy drug is set to be approved in US in early 2024
The party drug MDMA could become the 'first psychedelic-assisted therapy' if it gets approval from the FDA in 2024.
The Multidisciplinary Association for Psychedelic Studies (MAPS) has submitted the first-ever application for this type of therapy, which could get the go-ahead early in 2024.
The MDMA-based therapy pills are set to receive a decision from the FDA in January or February of 2024. The new drug, known as midomafetamine, is designed to help people with post-traumatic stress disorder (PTSD). It's meant to be used alongside therapy and other support services.
If approved, it will be the first time a psychedelic drug has been used to treat PTSD. Plus, the Drug Enforcement Agency would have to reschedule MDMA (currently a Schedule I drug), making it available for prescription medical use.
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The FDA is scheduled to approve a new drug that may help with PTSD (Getty Images/iStockphoto)Amy Emerson, CEO of MAPS Public Benefit Corporation, the research sponsor, said: "It's the first innovation in PTSD treatment in more than two decades. And it's significant because I think it will also open up other innovations,"
The FDA has already given midomafetamine a breakthrough therapy designation, and MAPS is asking the FDA for a priority review of the drug.
Emerson added: "The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades."
Scientists are awaiting the FDA's approval for legal, MDMA therapy (Getty)Approximately 13 million Americans suffer from post-traumatic stress disorder (PTSD) each year, and there's a high demand for better treatments as the current ones aren't very effective.
Midomafetamine, a type of MDMA commonly known as ecstasy, is currently classed as a Schedule I drug by the Drug Enforcement Agency because it can be highly addictive and abused.
The 'New Drug Application' included results from multiple studies, focusing on two major ones that investigated how effective and safe MDMA-assisted therapy was compared to a placebo in people with moderate to severe PTSD.
The studies were successful, analysing midomafetamine as a quick treatment involving three treatment cycles over 18 weeks.
Patients consumed MDMA under the careful surveillance of a healthcare professional who also offered psychotherapy. Three additional psychotherapy sessions followed this procedure.
Both trials, called MAPP1 and MAPP2, achieved their primary goals. The studies noted a marked improvement in "functional impairment associated with PTSD as measured by the change in the Sheehan Disability Scale," according to the publication known as Drug Topics.
Results from a second study, published in Nature Medicine in September 2023, revealed that 45 out of 52 (86.5 percent) patients treated with midomafetamine saw significant benefits. Furthermore, 37 out of 52 (71.2 percent) patients no longer met the criteria for PTSD by the end of the study.
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The treatment proved effective in both trials, regardless of factors such as disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences, or dissociative subtype. Both studies had a low dropout rate.
No serious side effects were reported in the MDMA group in both studies. The most common side effects were slight increases in blood pressure and pulse. Midomafetamine didn't seem to increase thoughts of suicide.
From January 2024, a new reimbursement code will be used for psychedelic therapies, which means they are figuring out the pricing, coding, and clinical source for medical specialty drugs.
The American Medical Association gave the green light to a Current Procedural Terminology (CPT) III code for these therapies in May 2023.
* An AI tool was used to add an extra layer to the editing process for this story. You can report any errors to [email protected]
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