Portugal authorizes psychedelic drug usage for severe depression cases
The National Authority for Medicines and Healthcare Products has announced that the drug Spravato will now be financed for hospital use in adults with treatment-resistant Major Depressive Disorder who have not responded to at least three different treatments with antidepressants. This decision, dated May 7th, will allow the use of Spravato, in combination with two other antidepressants, in the current moderate to severe depressive episode, according to specified conditions.
These conditions include the use of Spravato with combination or oral potentiation strategies, and its application is restricted to adults who have undergone psychotherapy and either have resistance or contraindications to electroconvulsive therapy, do not have access to this therapy, or have refused it.
On the same day, a working group comprising medical, pharmaceutical, and psychological associations, as well as the National Ethics Council, presented recommendations for the clinical use of psychedelics, suggesting that these substances should be classified as medicines.
Albino Oliveira Maia, director of the Neuropsychiatry Unit at Champalimaud and member of the working group, explained that, while the group does not intend to replace regulators, it contributes specifically in cases where there is no regulation yet approved. For instance, the use of ketamine, approved as an anesthetic, but also being used off-label for certain cases of depression, illustrates the need for such guidelines.
The working group emphasizes that, when used as medicine, there should not be exceptions to the safe and cautious application of these substances. The precise directions for the use of Spravato in treating treatment-resistant depression involve careful selection of patients, close medical supervision, and close adherence to a comprehensive treatment plan that includes oral antidepressants and may include psychotherapy.
Spravato is administered as a nasal spray in a certified healthcare setting enrolled in the Spravato REMS (Risk Evaluation and Mitigation Strategy) program, with the patients being supervised during administration and monitored for adverse effects for at least two hours post-dose. Only providers and healthcare settings certified in the Spravato REMS program are authorized to prescribe and administer this drug.
- Given the ongoing research in health-and-wellness, especially mental health, the working group's recommendations for the clinical use of psychedelics suggest that these substances should be treated as medicines, ensuring their safe and careful application in science-based therapeutic approaches.
- In line with the science-based approach for mental health, the precise directions for the use of Spravato in treating treatment-resistant depression emphasize its administration in a certified healthcare setting, under strict medical supervision and in conjunction with oral antidepressants, psychotherapy, and a comprehensive treatment plan.
