This year, the U.S. government will decide whether to approve the use of psychedelic drugs such as MDMA for the treatment of a range of mental health conditions. This milestone will not only be significant for patients in need of alternative therapies but also major players in the industry, including the Multidisciplinary Association for Psychedelic Studies (MAPS).
MAPS is a nonprofit organization that specializes in research and education on psychedelics. It was founded in 1986 by Rick Doblin, who has spent decades studying whether psychedelics — MDMD in particular — could help treat patients suffering from post-traumatic stress disorder. MDMA, which is also known as molly or ecstasy, is a psychedelic known to alter sensations, distort perception and time, and increase energy.
In 2021, the organization completed phase 3 trials evaluating the effectiveness and safety of MDMA-assisted therapy for patients suffering from severe post-traumatic stress disorder. The trial’s findings showed that those who received MDMA in conjunction with psychotherapy were two times more likely to recover from the disorder in comparison to participants given a placebo and psychotherapy.
MAPS has now concluded a bigger trial on the same, announcing that the trials results were also positive. Once the study’s findings are published, the organization plans to submit an application to the FDA asking that the agency approve its psychedelic formulation as a legal treatment for post-traumatic stress disorder.
The drug’s approval by the federal agency will be a historical decision, especially since MDMA is still classified as a Schedule I drug under the Controlled Substances Act. However, Doblin is confident that the process will be smooth, given how psychedelic-assisted therapy is being taken more seriously in other countries.
Earlier in the year, Australia approved MDMA as a treatment for post-traumatic stress disorder. It is important to note that the psychedelic will still be restricted. Other players in the burgeoning industry hope that crossing this threshold will also open the door for other therapeutic psychedelics, including psilocybin, LSD, ketamine and ayahuasca.
An analysis has forecasted that the psychedelics market may be worth more than $8 billion by 2028. However, the regulatory side of things will still have some issues to iron out, including who will administer MDMA as well as how it will be administered. This is a delicate area, since any issues that arise after the drug is approved may cause the public and political actors to turn against psychedelics, which will hinder progress greatly.
That aside, when MDMA is eventually approved by the FDA, it will arouse renewed interest in the work being done by other psychedelic industry actors such as atai Life Sciences N.V. (NASDAQ: ATAI) that are also working on product pipelines involving hallucinogenic compounds.
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