The Ministry of Health has approved the financing of esketamine, a drug to treat major depression resistant to treatment in a nasal spray format that acts quickly, reducing suicidal ideation, the need for hospital admission and the chronicity of the disease, as stated Henar Hevia, medical director of Janssen Spain, the pharmaceutical company that markets this drug under the name of Spravato®, which had already been approved in the US by the FDA more than three years ago.
Throughout this year, the Drug Price Commission (CIPM) had refused to finance this medicine on two occasions, but from now on it will be financed by the public health system and thus becomes the first and only treatment in nasal spray approved in our country for treatment-resistant major depressive disorder (MDD). Specifically, Spravato is indicated for adult patients with this type of depression who have not responded to two other prior treatments. Outside the public health system, this drug has a high cost, since each spray costs 312.95 euros.
Henar Hevia has indicated that it was an “uncovered medical need” and has highlighted the rapid action of this new therapeutic option, since traditional antidepressants take between five and eight weeks to take effect, and during this period “the risk increases suicidal”. Spravato, however, begins to produce positive responses within 24 hours of administration, and depressive symptoms subside in a large number of patients within four weeks.
How Spravato works to treat major depressive disorder
Major Depressive Disorder (MDD) is the most severe form of depression and is characterized by the fact that the symptoms experienced by the patient are the most severe of the group of depressive disorders, such as deep sadness and hopelessness, great difficulty paying attention or concentrating , tiredness, insomnia, negative thoughts about himself and the world, and suicidal ideas and behaviors. In addition, as Marina Díaz Marsá, president of the Madrid Psychiatric Society, explained, during the presentation of the drug, around 30% of people with depression have recurrent episodes and 15% will develop this pathology chronically, so it is It is essential to see a medical professional.
The World Health Organization (WHO) considers that depression will become the most important disease worldwide in 2030, a fact to which the COVID-19 pandemic has contributed to a great extent, which has significantly increased the cases of anxiety and depression. Specifically, and according to Dr. Díaz Marsá, “major depression increased (worldwide) by 28% in 2020, the year in which 53 million depressive disorders were registered, with young people and women being the most affected groups” .
Spravato constitutes “a paradigm shift in the treatment of the most serious depressions.” “69% of patients have a positive response and 53% remit the symptoms”
Spravato is for hospital use, which means that it will be dispensed in pharmacies in these centers and its administration will need to be supervised by a healthcare professional, which is administered intranasally using a spray containing 28 mg of the active ingredient. The dosage and regimen of drug administration varies depending on the age of the patient and the phase of treatment, although generally the doses to be administered are 28 mg (one spray), 56 mg (two sprays), or 84 mg. (three sprays), and is applied in combination with an SSRI or SNRI (selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor).
As they point out from the OCU, these sprayers are for single use. So once it is administered in each nostril it must be discarded. If it is necessary to administer more than one spray, wait 5 minutes between each dose.
At the moment it is indicated for adult patients who suffer from severe depression and have impaired enjoyment, a feeling of lack of energy, high anxiety and risk of suicide, but Josep Antoni Ramos-Quiroga, head of the Psychiatry Service at Hospital Universitario Vall d’Hebrón, who has participated in the clinical development of the molecule, has reported that its use is already being studied in the pediatric population and those over 65 years of age.
According to this expert, the new drug constitutes “a paradigm shift in the treatment of the most serious depressions.” The results obtained in clinical trials support the before and after that this drug entails: “69% of patients have a positive response and 53% remit the symptoms”, and its use will reduce hospitalization costs and improve quality of life. of patients and their families. In addition, the time it takes for other major depression treatments to take effect “translates into neuronal atrophy,” a situation that no longer occurs with Spravato, he concludes.
.
