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 (JNJ) 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.
“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.
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.