United States: Currently, the FDA has not made specific decisions on this research yet, but it is considering the idea that prescribers may be allowed to prescribe the substance that is used to produce MDMA or Ecstasy for the treatment of PTSD.
More about the finding
A scholarly panel of the agency that advises on research deliberated on studies on June 4 and approved the treatment totally. However, it is noteworthy that the FDA usually pays considerable attention to the suggestions of its advisory committees, as the New York Times reported.
The decision on this case is still pending and should be made in mid-August.
Lykos Therapeutics provided data from clinical trials to the agency in an attempt to get approval for the substance to be sold under legal jurisdiction to be administered to individuals who have taken MDMA alongside talk therapy.
Data indicate that millions of people in the United States live with PTSD, such as former military who attempt suicide most frequently. In fact, there has been a lack of a new treatment for PTSD for nearly 20 years.
As a matter of fact, millions from America are suffering from PTSD, including military veterans as well, who are considered at high risk of suicide, according to a recent report.
Moreover, no other treatment for PTSD has been approved in more than 20 years.
Know more about MDMA
Methylenedioxymethamphetamine (MDMA) is a synthetic, psychoactive substance synthesized for the first time by Merck in 1912.
Originally synthesized in the 1920s by chemists working for the pharmaceutical company Merck, it was forgotten until its revival in the mid-1970s by a psychedelic chemist called Alexander Shulgin in the Bay area of San Francisco, where it rapidly became popular among therapists.
In the initial trials, signs of a robust therapeutic value were aimed toward the treatment of a number of psychological disorders, as the New York Times reported.
MDMA is classified as an entactogen or empathogen and has beneficial effects that enhance self-realization, intimacy, and oneness with others.
It is not one of the groups that contain substances such as acid or shrooms, drugs that can create different realities and visions. Depending on the parts of the world where it is commonly used and the drugs and substance market, MDMA commonly goes by the moniker Molly or Ecstasy.
MDMA reached Britain in 1985 during the second wave of rave culture; it was also stated that the Drug Enforcement Administration has classified the drug as Schedule I; the substance is defined as having no medicinal use, and the effectiveness for usage is deemed high.
Negative effects on health
The FDA officials highlighted worries regarding “significant increases” in terms of blood pressure and pulse rates in those of the participating individuals in the Lykos clinical trials, where they noted about the risks that could “trigger cardiovascular events.”
Several scientists suggest the drug is a safe and nonaddictive entity in its pure form.
However, negative health effects, which are often observed outside of safe clinical settings, are noticed when the drug is used with other adulterants, such as methamphetamine and synthetic cathinone, often known as bath salts.
Some recreational users also report lower mood after consuming MDMA, majorly due to the time-consuming storage of serotonin in the brain. Experts believe that more research is still required to gain a better understanding of this area.