The United States Food and Drugs Administration (FDA) have approved for sale a new nasal spray containing Esketamine for the management of treatment-resistant depression.
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The drug brand named Spravato contains Esketamine as is manufactured by Janssen (14-2 in favour of the drug). It is claimed to lift the mood of the patient within 24 hours of use. At present it is to be prescribed only in patients who have not responded to two other conventional antidepressants. Other antidepressants usually take weeks to show their efficacy. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said in s statement, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”
The spray received its initial approval from the FDA’s advisory panel in February. It has been slated to cost around $885 (£673) per treatment. Janssen said in a statement that this spray of Spravato is a “potential therapy for adults living with treatment-resistant depression.” They have said that it greatly helps patients with suicidal thoughts.
Experts have said that while conventional antidepressants like the SSRIs or Fluoxetine or Paroxetine, Escitalopram etc. reduce depressive symptoms by increasing release of a chemical serotonin in the brain, Esketamine acts differently. Serotonin released by SSRIs can affect the mood and sleep in a positive way. Esketamine increases glutamate in the brain. This is liked to memory and learning in the brain.
Esketamine has been advised to be used as a adjuvant along with other conventional antidepressants. The drug is sprayed into the nose and from there it is absorbed via the blood stream. Gerard Sanacora, a psychiatrist and the director of the Yale Depression Research Program said in a statement, “I have no doubt in my mind that this is a very useful treatment. [But this] has to be balanced with, how do we use this rationally, and in what step in care do we use this medicine.”
On the flip side the drug is capable of inducing suicidal thoughts and this will be printed as a “boxed warning” on the label of the preparation. It can also lead to a sense of dissociation or detachment from one’s self or identity. Thus each time the patient takes Spravato, they need to be monitored for at least two hours, the manufacturers warn. Long term safety of the drug is also unknown yet. The treatment can be only prescribed by a certified provider and should be administered under supervision.
The European Medicines Agency (EMA) is also considering a similar application.