Thursday, 21 March, 2019

FDA Approves Nasal Spray Depression Treatment Spravato Based On Club Drug Ketamine

J&J nasal spray gets U.S. approval as first new type of anti-depressant in decades FDA approves new treatment for depression in the form of nasal spray
Celia Hoffman | 08 March, 2019, 21:43

In the longer-term maintenance-of-effect trial, patients who continued the use of Spravato experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray and oral antidepressant. The drug is created to start working in hours instead of weeks.

The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's (NYSE:JNJ) nasal spray antidepressant that is chemically similar to often-abused ketamine, marking the first advance in treating depression in more than 30 years. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.

The drug, a nasal spray called esketamine, has been eagerly anticipated by psychiatrists and patient groups as a powerful new tool to fight intractable depression.

Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant. But he cautioned there is still much that isn't known about the drug, particularly regarding its long-term use.

"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".

The drug comes in the form of esketamine, a mirror image of the ketamine molecule, which is far more potent.

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Then, two years ago, he began receiving ketamine as part of a clinical trial.

"This is an exciting development and the first novel mechanism that goes beyond the current serotonin treatments", Dr. Sanjay Mathew of the Anxiety and Depression Association of America said in an interview.

The list price of a drug is not necessarily what patients actually pay. 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. He's administered Ketamine treatments for the past eight years, taking in those who have failed with other antidepressants and are at risk for suicide.

The FDA approved the drug with restrictions to address those concerns.

The immediate impact of ketamine is thought to last just four to seven days and there's no consensus yet on how long patients can benefit from ongoing treatment. Given in low doses through infusions, he says Ketamine is safe and effective.

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