The U.S. Food and Drug Administration approved Johnson & Johnson’s nasal spray esketamine for treating depression in patients who have not responded to other therapies, designating it as the first new class of antidepressants in over 30 years. The drug, marketed as Spravato, carries strict usage restrictions to mitigate risks of abuse and misuse.
Esketamine, a nasal spray derived from the anesthetic ketamine, will be administered exclusively in medical settings under physician supervision. Patients cannot take the medication home, reflecting concerns over its potential for recreational use. The drug’s approval follows clinical trials showing rapid symptom relief in some patients, with effects observed within 24 hours.
Manufactured by Janssen Pharmaceuticals, Spravato works by restoring neural connections in brain regions linked to mood regulation. It is intended to be used alongside an oral antidepressant and carries a boxed warning highlighting risks of sedation, cognitive impairment, and increased suicidal thoughts. The FDA’s decision came after an advisory panel concluded the drug’s benefits outweigh its risks, despite concerns about side effects like elevated blood pressure and dissociation.
The approval coincides with growing demand for alternative treatments, as existing antidepressants often take weeks to work and fail to help 30% to 40% of patients with major depressive disorder. Janssen emphasized the drug’s potential to transform treatment paradigms, particularly for individuals with treatment-resistant depression. Over 300 million people globally live with major depressive disorders, a condition associated with a 20-fold higher suicide risk compared to the general population.
A 2017 photo of a Johnson & Johnson facility in California accompanies the report, illustrating the company’s long-standing presence in pharmaceutical development.
