The Ministry of Health approves a new drug for patients who have not responded to at least two different antidepressant treatments.
major depressive disorder It affects nearly 40 million people of all ages in Europe and is one of the leading causes of disability worldwide. In Spain, the Ministry of Health has given the green light to a new treatment (esketamine for nasal spray), for treatment-resistant major depressive disorder, a type of medication that until now did not exist. An innovation that comes to respond to a “unmet medical need”According to the doctor Josep Antoni Ramos-Quirogahead of the Psychiatry Service at the Vall d’Hebrón University Hospital in Barcelona.
The new drug, from the Janssen Pharmaceutical Companies of Johnson & Johnson, was presented today in Madrid. It is indicated in combination with an SSRI or SNRI (selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors) in patients who have not responded to at least two antidepressant treatments different.
As detailed by the doctor Josep Antoni Ramos-Quiroga It is a new option for people who suffer from the most serious depressions, who, after several treatments, they just don’t get better. “Standard antidepressants have a mechanism of action it takes between four and eight weeks to start seeing results, and this therapy provides a mechanism of action that, within hours of its administration, already allows us to see positive results. Until today, we did not have antidepressants that had demonstrated their efficacy in these severe depressions.”
Early diagnostic
The president of the Spanish Society of Psychiatry and Mental Health (SEPSM), Dr. Víctor Pérez Sola, for his part, pointed to depression as one of the leading causes of disability in the world and although there are treatments effective biological and psychologicalhe pointed out, there are still challenges in early diagnosis and in those patients who do not respond to current treatments, what doctors call treatment-resistant depression that occurs in 30-40% of patients with this disease.
The experts also underlined the impact of the pandemic on the mental health of the population. As pointed out by Dr. Marina Diaz Marsa, president of the Madrid Psychiatric Society, “major depression increased by 28% in 2020, the year in which 53 million depressive disorders were registered.” Young people and women are the most affected groups. In fact, the World Health Organization (WHO) predicts that it will become the most important disease in Europe and worldwide in 2030.
In the case of major depressive disorder, it is usually recurrent in 75-80% of patients, it becomes chronic (lasting 2 years or more) in 15 to 20% of this group and this, the specialists indicate, can lead to a substantial impairment in a person’s ability to perform adequate functional activity, often leading to ideation or suicidal actsdoctors warned.
For the diagnosis of major depressive disorder, explained, five or more of some of these symptoms must be present for at least two weeks, and one of them must be depressed mood or lack of interest or pleasure in all or almost all activities: significant weight loss, insomnia, lack of of energy, feelings of worthlessness or guilt. Among the challenges is that one in three patients does not respond to treatment with conventional antidepressants, in addition to, as has been said, increased risk of suicide that patients have, 20 times higher than the rest of the population.
Trials in 1,600 patients
The approval of intranasal esketamine is based on data from a clinical trial program that has included more than 1,600 patientsincluding Spanish. The five phase III trials included three short-term studies, one randomized relapse prevention study, and one long-term safety study. These data have shown that treatment, plus a new-onset oral antidepressantwas associated with a greater reduction in depressive symptoms compared with a new-onset oral antidepressant plus placebo nasal spray, in adult patients (18-64 years), being effective from the first 24 hours.
About 70% of treated patients responded to treatment, with a reduction in symptoms. For Dr. Ramos-Quiroga, this therapy represents a paradigm shift in the approach to the most serious depressions. “This is going to change the way we do things with patients who require an average hospital stay of about a month. Now, in a few hours, days, we can reduce hospital stayswith what this entails for their quality of life and savings for the health system,” he assured.