J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action to treat major depressive disorder.
Fourteen members of the committee voted that the data support a favorable benefit-risk profile for Spravato. Two members voted no and one abstained, according to Janssen.
The FDA is slated to make its final decision by March 4.
“We are pleased with the advisory committees’ vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression,” Dr. Husseini Manji, global head of Janssen R&D’s neuroscience therapeutic area, said in prepared remarks. “Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression.”
Spravato is an intranasal formulation of a drug called ketamine, also known as ‘Special K’. There is a link between longtime use of ketamine and neurotoxicity, but Janssen reported that one-year data from a safety study showed that esketamine was generally tolerable. The company is reportedly planning on a post-market safety study for the product, according to Endpoints News.
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