Janssen’s esketamine drug recommended by FDA panel for depression

pharmafile | February 13, 2019 | News story | Research and Development, Sales and Marketing FDA, Janssen, Spravato, depression, esketamine, major depressive disorder, pharma 

In a rare and welcomed development in the treatment of major depressive disorder (MDD), Janssen has announced that its esketamine nasal spray Spravato has been recommended by the FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee for the treatment of treatment-resistant depression.

The panel voted overwhelmingly in favour of the drug, with 14 voting yes, just two voting no, and one abstention. While the ruling is not binding, the final decisions made by the FDA are generally in line with the panel’s recommendations.  

Spravato offers a different mode of action to the common selective serotonin reuptake inhibitors (SSRI) therapies for depression, being a chemical mirror image of the anaesthetic ketamine, which is often used recreationally.

“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,” said Dr Husseini K Manji, Global Head, Neuroscience at Janssen Research & Development. “Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression.”

Janssen is currently awaiting the FDA’s decision on whether or not to approve the drug; if approved, it would make Spravato the first MDD drug with a new mechanism of action in 30 years.

Matt Fellows

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