Spravato will be financed and can be used in hospital medium in adults who did not respond to at least three different antidepressants treatments.
Infarmed approved the public funding of the first drug with Escetaminaa psychoadelic considered the “chemistry” of ketamine, to be used in hospital environment in adults with severe depression.
In a statement, the National Authority for Medicine and Health Products reports that the drug in question, Spravatoit is now financed, for use in hospital environment, in adults “with depressive disorder disturbance resistant to treatment, which did not respond to at least three different treatments with antidepressants.”
According to the decision on May 7, Spravato, in association with two other antidepressants, can be used “with oral combination or potentiation strategies, in the current moderate to severe depressive episode” in adults who have performed previously psychotherapy and have resistance or contraindication to “therapy with electroconvissivotherapy”, have no access or refused this therapy.
By 2019, ZAP already marketing spavrate in the form of nasal spray to treat severe depression in the US.
Experts present recommendations
The news comes on the same day as a working group that includes the orders of doctors, pharmacists and psychologists and the National Ethics Council presents a set of Recommendations for clinical use of psychoadelicarguing that they are framed as medicines.
“The way to access them [medicamentos] requires a prescriptive And that, after the issuance of the prescription, the patient resorts to a medical, clinical and pharmaceutical system that allows him to access that substance, ”Lusa Albino Oliveira Maia, director of the Champalimaud Neuropsychiatry Unit and member of the working group.
Stressing that “there should be no exceptions,” he recalls that sometimes substances, even being medicines, can be unduly used in parallel marketing circuits.
“Psychoadélica are not a unique case in relation to substances where there may be interest of consumption outside the medical system and within the medical system,” said the investigator, adding: “The circumstance that is specific in this case is that we are making a movement to transform drugs of substances that exist outside the medical, pharmaceutical and clinical world.”
The document with the recommendations, which will be presented at 17:30, in the auditorium of, had the contribution of the orders of doctors, pharmacists and psychologists, as well as the National Council of Ethics for the Life Sciences and the Portuguese Society of Psychiatry and Mental Health.
Speaking to Lusa, Albino Maia stressed that this working group does not want to replace the regulators, but only contribute, especially in cases where there is no approved regulation yet.
As an example, referred to the use of ketaminewhich is approved as anesthetic, but is also being used (‘off label’) for some cases of depression.
“From the point of view of the use of these substances as a medicine, we should not have an exception regime,” said the investigator, adding: “What we are saying is what to shelter precautionary principles when there is still not enough evidence for regulatory entities to pronounce.”
It is recalled that the Champalimaud Foundation has been at the forefront of the attempt to accept treatment with the use of psychoadelic, and has even tested “magical mushrooms” in palliative patients in Portugal.
