There it is.
Despite some serious clinical failures, the FDA has approved J&J’s new drug esketamine for major depression, which will now hit the market as Spravato.
An intranasal formulation of ketamine, a horse tranquilizer that is better known in party circles as Special K, the drug won a warm assessment by FDA insiders as well as an overwhelming vote in its favor by a panel of outside experts organized by the FDA.
The experts and regulators were won over by the fact that most were aware of ketamine’s years-long reputation for dealing quickly with the most severe kinds of depression. J&J touted the data that they had acquired in late-stage research, downplaying the failures. But in depression physicians are already well used to dealing with hit-and-miss therapeutic strategies, armed with a haphazard set of depression drugs that often don’t work.
This drug will be given only under careful supervision and a black box warning regarding the risk of sedation and dissociative behavior. It is one of J&J’s top late-stage programs, tapped as a potential blockbuster.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, the acting director of the Division of Psychiatry Products in FDA’s Center for Drug Evaluation and Research. “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. Because of safey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”
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