Ketamine-Like Nasal Spray Approved For Depression Treatment In The US

Alicia Farmer
March 12, 2019

"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment", added Farchione. Janssen said in a statement that this spray of Spravato is a "potential therapy for adults living with treatment-resistant depression". Like any new medication, it comes with many questions; clinical studies before FDA approval are limited in the number and type of patient they include, meaning that more information only comes to light when new drugs reach the "real world".

US health officials have approved a medication related to the mind-altering drug ketamine as a new option for patients with severe depression.

The treatment is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS), because of the risk of adverse outcomes resulting from sedation and dissociation.

A variant of the party drug Ketamine has been licensed in the United States for treatment-resistant depression.

Esketamine works through a mechanism different from those of drugs like Prozac, Charney said.

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The Food and Drug Administration has recently approved a nasal spray antidepressant based on the widely used anesthetic, ketamine.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening. In the longer study, patients whose conditions had stabilized and continued to take the nasal spray in conjunction with an oral antidepressant took a "statistically significant longer time" to relapse than patients who received a placebo nasal spray with their oral antidepressant. In a recent interview with Scientific American, Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, said the drug had undergone only one government-supervised trial and needed a second.

"Spravato will not be dispensed directly to a patient to take at home", he said.

A decades-old drug, ketamine is already used off-label to treat depression by some doctors. "It will only be available in approved and certified treatment centers". After receiving a Spravato dose, a patient must be monitored by a healthcare provider for at least two hours. J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive.

During the one-month induction phase, treatment with Spravato would cost between $4,720 to $6,785.

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