HEALTH
Depression drug related to ketamine wins endorsement of key advisory panel
By MEGAN THIELKING @meggophone
FEBRUARY 12, 2019
DANIEL HULSHIZER/AP
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 depressionone step closer to approval.
The drug — delivered in a nasal spray — is the chemical cousin of 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.
Related:
Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits
One panelist, Dr. Jess Fiedorowicz of the University of Iowa, abstained from the vote.
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.