It is the first major treatment for depression to arrive on the French market for several decades. First authorized by the Food and Drug Administration (FDA) in the United States, then by the European Commission last January, it is a nasal spray based on esketamine, marketed under the name Spravato by the Jannsen laboratory. Used in combination with oral antidepressants, it is a new option for patients who do not respond to already existing treatments, such as fluoxetine (Prozac).
Medication prescribed only in hospital
“This is a major development in the treatment of depression”, declared at the end of the first two clinical trials Dr. Pierre de Maricourt, head of department of the Sainte-Anne hospital in Paris. Esketamine would indeed act very quickly – after only a few days. While the antidepressants currently on the market can take several weeks to have an effect. The molecule would also help fight suicidal thoughts. It therefore appears to be a promising option for patients suffering from “treatment-resistant” depression, ie who have not responded to at least two different antidepressants.
But there is no question of asking your doctor for a prescription for Spravato. The drug is intended for administration under the direct supervision of a physician in a hospital or clinic. This helps to monitor possible side effects because the molecule is considered a narcotic, and can cause problems with high blood pressure or sedation. “The prescribing decision must be taken by a hospital psychiatrist and its follow-up must be carried out by a health professional qualified in the management of blood pressure” can we read in the guide for patients disseminated by the National Medicines Safety Agency (ANSM).
A drug under surveillance
One of the fears raised by the use of this new drug, however, lies in its composition. THE’esketamine is a derivative of ketamine, a veterinary anesthetic sometimes used as a euphoric drug to intensify sensory perceptions. According to the Janssen laboratory, dissociative effects (sounds appear louder, colors appear brighter, or the patient feels like they are outside of their environment or their own body) have indeed been observed during clinical tests of phase 3 in 26% of patients, less than an hour after taking the drug. These effects usually disappeared within hours of administration of the drug.
The drug has been granted temporary authorization for use in adult patients under 65 with characterized depressive episodes who have not responded to at least two different antidepressants from two different classes during the current severe depressive episode . And in case of contraindication or resistance to electroconvulsive therapy or for patients who do not have access to it or who have refused it.
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