Australia will allow, from July 1, the use of medicines containing two psychedelic drugs: the psilocybin (present in the so called hallucinogenic mushrooms) and the MDMA (known as ecstasy) to treat, respectively, the resistant depression and the posttraumatic stress. Australia thus becomes the first country in the world to approve the use of psychedelics in targeted therapies (i.e., under medical supervision) to address both of these two mental illnesses.
The Therapeutic Goods Administration (TGA) has issued a statement permitting both substances to be prescribed by “specifically licensed psychiatrists for the treatment of certain mental health ailments.” There are “sufficient evidence of potential benefits for some patients.” assures the paper. The covid pandemic and the ensuing increase in mental illness has highlighted the need to advance therapies beyond conventional ones.
The psychedelics research to treat mental illness has experienced a boost in recent years. The U.S., a pioneer in this field, has already launched the phase three (the pre-marketing of the drug) of two trials: one of the MDMA to treat post-traumatic stress and another of the psilocybin (both now approved in Australia). In addition, similar studies are also being carried out in Europe and specifically in Catalonia, although they go a little behind those in the USA.
“What Australia has now decided is. Not to wait for the commercialization process of these drugs. and to allow therapists to prescribe them in patients who have not benefited from the conventional therapies.” points out the psychopharmacologist Antón Gómez-Escolar Sanz, author of ‘Guía esencial del renacimiento psicodélico’ and member of the Spanish Society of Psychedelic Medicine (Sempsi). Gómez-Escolar stresses that these substances will be administered within the framework of a assisted psychotherapy, i.e., within a medical programin a limited time frame and with the supervision of psychologists and psychiatrists.
The doubt is in how, if the drugs are not yet being. commercialized, will be given to the patient. It is, according to this psychopharmacologist, a “middle way” to treat people before the drug is put on sale. He does not believe that there will be many problems in this regard, because the use of the psychedelic substance will be “punctual.” And under “medical supervision.” “It’s not something that will sell in pharmacies, but it will suffice for the physician to have access to them on a timely basis,” he specifies.
Australia’s regulator allows the prescription of the synthetic drug MDMA for the treatment of post-traumatic stress syndrome and psilocybin For depressions that do not improve with other treatments. “These are the only two illnesses for which we there is sufficient evidence of potential benefit for some patients.” said the statement issued last week.
To prescribe drugs containing these substances, psychiatrists must receive approval from the Therapeutic Goods Administration (TGA), which will submit it to the judgment of a ethical research committee. The TGA recognizes the “lack of options” for mentally ill patients who resist treatment, but remember that the following are necessary controls for possible adverse effects of these therapies and that, for uses other than the two ailments mentioned, they remain prohibited substances.
Although there are no authorized products containing either of these two substances on the Australian market, the TGA will allow licensed psychiatrists to legally supply themselves with “unapproved drugs” containing them. “Important step.”
For Gómez-Escolar, Australia’s is. an “important step” in advancing the use of psychedelics to treat some mental illnesses. “In countries such as Canada o Switzerland something similar has already been tried. But there it is usually for more serious cases. In Canada, for example, they are administered in situations of terminal diagnosis.” points out this expert.
He believes that, in the case of Spain, “there is still a long way to go”. The US, however, is “very close.” “Europe is two to three years behind the US,” says Gómez-Escolar. In North America, the use of MDMA and psilocybin is expected to be approved “by the end of this year” or “early next year.”
In Catalonia, the Sant Joan de Déu Hospital (Esplugues de Llobregat) has already initiated the clinical trial with the psilocybin, phase three of which will be carried out by Vall d’Hebron Research Institute (VHIR). Both centers will also carry out phase three of the study with MDMA. Sant Joan de Déu, VHIR and the Hospital Clínicin addition, they are also going to investigate the hallucinogenic 5-MDMT for resistant depression (that which does not respond to conventional drugs).