The US Food and Drug Administration has approved a new depression supplement, esketamine, for patients who have not responded to other antidepressants. The treatment, a nasal spray that is related to the particle drug ketamine, will be the first fast-acting depression drug on the market.
Unlike most older antidepressants, esketamine (which will be marketed as Spravato) lifts patients' mood within hours. Other antidepressants now available can take weeks if they work at all. The drug, developed by Johnson & Johnson's Janssen subsidiary, is intended to be used with another antidepressant, and only by people who have already tried two and are not feeling better. Esketamine works differently from traditional antidepressants
Part of the tension around esketamine comes from the fact that it works differently from traditional antidepressants such as Prozac. Prozac, originally marketed by Eli Lilly and approved in 1
Over the past decade, as small studies suggested that ketamine can help people who are depressed, feel better, clinics that promise ketamine treatment for depression have been up in the US. These promise quick relief, but are largely unregulated, deviate from accepted research and are not covered by insurance.
The FDA approval specifically states that the drug will only be available in certified clinics where doctors can monitor the patient, drafts designed to significantly reduce the risk of abuse. The treatment is still not cheap: it can cost nearly $ 900 per session, which would cost one month, at the recommended two sessions a week, to nearly $ 7,000, according to State News . However, with the FDA approval, esketamine treatments are likely to be covered by insurance and that it will have fewer side effects than ketamine, which can cause nausea, vomiting and sleepiness.
Still, esketamine will carry the FDA's deepest warning – a black box that says there is potential for this drug to be abused. The boxed warning also indicates that the drug may cause suicidal thoughts.
Doctors have been divided on the FDA's approval of the drug, which was previously fast track and was termed a breakthrough therapy. While some are anxious to re-treat a field without much movement, others expressed concern that adequate safeguards would be introduced to administer the drug responsibly. "I have no doubt that this is a very useful treatment," said Gerard Sanacora, a psychiatrist and head of the Yale Depression Research Program State News which added that benefits have "To be balanced with how to use we this rationally and in what care we use this drug. "
Erick Turner, a former FDA reviewer and a professor of psychiatry at Oregon Health & Science University, struck a balanced picture of promises of the new treatment. "Thankfully, we now have something with a different mechanism of action than previous antidepressants," he told the New York Times . "But I'm skeptical of the hype, because in this world, Lucy is holding football to Charlie Brown: Every time we hop on, football is pulled away."