Esketamine has been approved this week by the The Food and Drug Administration (FDA) to treat major depression. Esketamine is the first major depression treatment to hit the U.S. market in decades. Best of all, it gives patients who no longer respond to current drugs, new hope for a good quality of life. In addition, it is extremely fast acting, faster than current depression drugs on the market.
The drug is manufactured by Janssen Pharamaceuticals and comes in the form of a nasal spray. Its major component is ketamine, a common anesthetic, and it works faster than existing, Prozac based antidepressants. It will be marketed under the name Spravato.
This is a very expensive drug. The protocol calls for two treatments per week and the cost will range from $4720 to $6785.
However, Janssen expects that treatments will be covered by insurance, which will certainly help depression sufferers who currently do not respond to the standard treatments.
Patients should be aware that Spravato has major and serious side effects.
The drug’s labeling will include a warning that patients who take esketamine are at risk for sedation Issues with attention, judgement, and thinking can occur. It will also warn that there is a risk of misuse, abuse, and suicidal thoughts after taking this drug. Patients who receive the drug must be monitored for at least two hours following a treatment session.
The FDA will have a strict monitoring program in place to prevent diversion and misuse. This includes strict distribution requirements as well as a suspicious order monitoring program.
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