The company’s product, Spravato, is an intranasal formulation of ketamine – a horse tranquilizer that is also known as Special K. The drug won support for approval from an FDA advisory committee earlier this year.
Spravato is the first new drug to be approved for depression in decades. J&J touted that in both short and long-term studies, people who received Spravato with an oral antidepressant saw superior improvement in depression symptoms and sustained improvement over time compared to those who received just an oral antidepressant.
In its approval, the FDA warned that Spravato comes with risks due to the sedation and dissociation that results from administration of the drug. The agency has made the drug available through a restricted distribution system.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the FDA’s division of psychiatry products, said in prepared remarks. “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.”
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” Dr. Mathai Mammen, global head of J&J’s R&D unit for Janssen, said in a statement. “This unique and innovative medicine is a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”