Esketamine Approved for Treatment-Resistant Depression
Esketamine Approved for Treatment-Resistant Depression
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12 March, 2019, 17:55
The agency hopes that the new drug will benefit those who find no relief from antidepressants now available in the market. Spravato is meant to treat patients who have major depressive disorder (MDD) and have not responded "adequately" to two at least two different types of antidepressants.
The new drug from Johnson & Johnson acts on different brain chemicals than decades-old antidepressants like Prozac. In comparison, many antidepressants now available can take weeks, or even months, to have an effect. The nasal spray is a mirror image of the chemical "anesthetic ketamine", popular as a recreational party drug, which is known locally as the "Special K".
A variant of the party drug Ketamine has been licensed in the U.S. for treatment-resistant depression. J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive.
Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness.
Turner serves on the FDA advisory committee that recommended last month that the FDA approve esketamine, but didn't take part in that meeting.
The ketamine-like drug is the first of several psychoactive substances making their way through the US regulatory process as physicians search further afield for new therapies.
"My concern is that we don't really how it gets people un-depressed", Mark George, MD, a psychiatrist and neurologist at the Medical University of SC in Charleston, tells Health.
The FDA approval is a significant milestone not only for the company but for those living with MDD. The drug's labeling will also warn about the risks of misuse, abuse, and possible suicidal thoughts.
Clinical trials suggest it is up to 10 times more effective than current drugs in people suffering from treatment-resistant depression.
Unlike ketamine, psilocybin and MDMA have no legal medical use. Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said. "It really has opened up a whole new way of thinking about depression", Gerard Sanacora, professor of psychiatry at Yale University School of Medicine and director of the Yale Depression Research Program, said of ketamine. He said the approval legitimizes the approach he and other doctors have been taking. It did not, however, reveal the drug's list price. At two sessions a week, the cost is upwards of $4,720 in the first month.
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