Published: Fri, March 08, 2019
Medical | By Vicki Mclaughlin

J&J's nasal spray antidepressant wins US approval

J&J's nasal spray antidepressant wins US approval

A formulation of the drug ketamine has received Food and Drug Administration approval as the first treatment for depression with a new mechanism of action in decades.

Ketamine is commonly known as Special K, an illegal party drug common at raves. Here & Now's Jeremy Hobson speaks with Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in NY.

"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".

If you or someone you know may be considering suicide, contact the National Suicide Prevention Lifeline at 1-800-273-8255 (En Español: 1-888-628-9454; Deaf and Hard of Hearing: 1-800-799-4889) or the Crisis Text Line by texting 741741. Then she became part of a trail for Ketamine treatment. This is due to strong potential for abuse and misuse of the drug, as it contains a compound similar to street-drug ketamine. That's about 5 million of the 16 million Americans with depression.

A nasal spray containing chemicals closely related to ketamine has been approved for use in the U.S. in the treatment of depression - but it will be highly regulated to avoid misuse of the drug.

"This offers hope, in capital letters", said Charney, who is a co-inventor on a patent on the use of ketamine as a depression treatment that has been licensed by Johnson & Johnson.

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The agency hopes that the new drug will benefit those who find no relief from antidepressants now available in the market.

The approval comes after an FDA advisory panel in February voted heavily in favor of the drug esketamine, saying its benefits outweighed the risks.

Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness. The most common adverse effects seen in the trials were disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, and vomiting. The treatment can be only prescribed by a certified provider and should be administered under supervision.

During clinical trials, Spravato was found to relieve depression symptoms within 24 hours in some patients, said Janssen spokesman Greg Panico.

Courtney Billington, the President of Johnson & Johnson's Janssen neuroscience division said that they have worked relentlessly to ensure that they have available resources with them to help patients with severe depression and the patients who were awaiting a quicker solution to get relief.

Older antidepressants target the neurotransmitters serotonin, norepinephrine or dopamine. A decade ago, he noted, companies began to abandon the effort. "It's really opened a whole new vista of opportunities and has changed the way we think about the pathophysiology of depression in some ways".

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