An experimental medication for depression related to the hallucinogenic street drug ketamine won a crucial endorsement from an independent advisory committee convened by the Food and Drug Administration on Tuesday.

In a 14-to-2 vote, the panel said the benefits of the Johnson & Johnson drug, known as esketamine, outweigh the risks. The vote brings the novel type of rapid-acting treatment for depression one step closer to approval.

The drug — delivered in a nasal spray — is related to the anesthetic ketamine. If approved, it would be the first major depression treatment approved in decades. The drug was tested in combination with oral antidepressants as a therapy for treatment-resistant depression.

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“I believe esketamine has the potential to be a game-changer in the treatment of depression,” said Dr. Walter Dunn, a panelist and psychiatrist at West Los Angeles Veterans Administration Medical Center.

One panelist, Dr. Jess Fiedorowicz of the University of Iowa, abstained from the vote.

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In its briefing submitted ahead of the hearing, the FDA expressed concern that patients could be harmed if they experience dissociation, or an out-of-body experience that can leave people less aware of their surroundings. The agency also noted six deaths — including three suicides — among patients who were taking the drug. But FDA reviewers said that given that it was just a handful of cases and the patients had severe illnesses, it’s “difficult to consider these deaths as drug related.”

Experts have also expressed concern that there might be a high potential for abuse, given that ketamine is commonly abused. But the committee — which voted 15-to-2 in favor of the drug’s safety profile — said that the risk of abuse appears to be low.

Members of the committee did emphasize the need for a robust strategy to prevent diversion, misuse, and other safety issues — and raised concerns about the need for more long-term data on esketamine’s effects.

“I don’t think we really understand what happens when you take this week after week,” said Steve Meisel, a panelist and the director of medication safety at Fairview Health Services in Minneapolis.

The FDA has granted esketamine a breakthrough-therapy designation. The panel’s vote will play a part in the agency’s decision on whether to approve the drug, expected by March 4.

  • Are you looking for test subjects? I would be willing. I’m 52. I’ve struggled with depression all of my life. I have been doing EMDR for the past 2 years.

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