In the US, an application was submitted for the approval of “ecstasy” for the treatment of PTSD
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The US Food and Drug Administration (FDA) may consider an application for the use of MDMA (“ecstasy”) to treat post-traumatic stress disorder.
The application to the regulator was submitted by MAPS Public Benefit Corporation, which studies the “advantages” of psychedelic drugs, reports The Washington Post.
The company is proposing to approve the use of the psychedelic drug methylenedioxymethamphetamine to treat PTSD in combination with psychotherapy.
This application shows the desire to transfer psychedelic drugs from the category of “strictly restricted substances” to the category of “generally available medical products” for patients.
Previous studies have shown that psychedelics, including psilocybin (“mushrooms”) and ketamine, can be used to treat mental disorders.
“If MDMA therapy is approved, it will be the first psychedelic therapy, which we hope will spur additional investment in new mental health research.” said Amy Emerson, executive director of MAPS.
The regulator has 60 days to accept or reject the application for consideration, as well as to decide which approval path it will follow – priority (6 months) or standard (10 months).
Photo: designer491/Depositphotos |
If the FDA approves the application, the U.S. could impose strict rules on who can prescribe MDMA and which pharmacies or facilities can dispense it, said Mason Marks, a senior fellow at Harvard Law School’s Project on Psychedelic Law and Regulation.
Health care facilities may be required to provide patients with an appropriate place for supervised MDMA consumption and supervision for a period of time, Marks adds.
It is currently unclear how the authorities will decide who has the right to prescribe MDMA, and what to do with doctors who could potentially prescribe the psychedelic “off-label”.
As a reminder, methylenedioxymethamphetamine or MDMA is a semi-synthetic psychoactive compound of the amphetamine series, which belongs to the group of phenylethylamines. MDMA is known by the slang name “ecstasy”.
Currently, the psychedelic is prohibited in Ukraine and a number of other countries, both for use in medicine and for storage or sale. MDMA is often used “for highs”, it carries the risk of addiction and other negative consequences for the body.
However, some studies suggest that the use of MDMA may be effective in treating PTSD and reducing symptoms. One such randomized study was published this year in the journal Nature.
Read also: PTSD during the war: how to recognize and recover from stress disorder
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