Esketamine Nasal Spray Receives FDA Approval for Treatment-Resistant Depression

FDA Just Approved the First Ketamine Based Fast-Acting Depression Drug

"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.

Some 16 million people in the USA 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. 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".

The approval is a significant milestone in the treatment of depression.

The Food and Drug Administration approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants.

The ingredient in Spravato, chemically similar to ketamine, is causing concerns for possible abuse or misuse.

People are considered to have treatment-resistant depression if they've tried at least two antidepressants without success, the agency said.

The FDA is requiring patients who are prescribed the drug to be monitored closely, due to the possibility of negative reactions of sedation and disassociation tied to the drug.

The drug is created to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion. It just became the first new kind of depression medication in 35 years. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days. 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.

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. He has researched ketamine and used it to treat depression.

Patients will inhale the drug under supervision at these centers once or twice a week. By the second month, a patient will receive treatment once a week or every two weeks, which will reduce the cost to between US$2,3000 and US$3,500 per month.

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