Esketamine Approved for Treatment-Resistant Depression

Grant Boone
March 12, 2019

Some 16 million people in the US have major depression, and one-third of them have not responded well to available treatments and may therefore be considered to have treatment-resistant depression.

Earlier this year, an FDA advisory body voted 14-2 in favour of the Johnson & Johnson drug, based on three short-term clinical trials and one longer-term maintenance-of-effect trial.

Jeffrey Lieberman, a Columbia University psychiatrist, described the FDA approval as "undeniably a major advance".

"We know that for someone who has failed two traditional antidepressants, if you try a third of the now approved medications, there's a [small] chance to achieve remission", said Dunn, who served on an FDA advisory panel which recommended approval of Spravato last month by a vote of 14-2.

The drug will only be available through a restricted distribution system.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press release about the decision.

Only one other drug, a combination of olanzapine and fluoxetine, is approved for treatment-resistant depression, although there are several drugs used off-label. Because of these concerns, the drug must be taken at a certified health care provider's office and patients are to be monitored for two hours after receiving it, according to. the statement.

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The drug is created to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.

The FDA's approval of Spravato, known generically as esketamine, came less than a month after expert advisers threw their support behind the spray.

The U.S. Food and Drug Administration approved a new anti-depressant with a chemical similar to 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 that trial, patients in stable remission on Spravato were 51% less likely to relapse compared to those who continued on a regimen of placebo plus oral antidepressant. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". The drug can not be taken home for unsupervised use.

Spravato will cost between $590 and $885 per treatment. It did not, however, reveal the drug's list price. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000.

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