The FDA has approved Johnson & Johnson's Spravato (esketamine) as a standalone treatment for adults with major depressive disorder (MDD) that is difficult to treat, according to a report by CNBC. The nasal spray was previously only approved for use in conjunction with an oral antidepressant for adults with treatment-resistant depression, who have had an inadequate response to at least two oral antidepressants. Now, Spravato is available for use with or without an oral antidepressant, giving patients with treatment-resistant depression another option.
Spravato, derived from ketamine and known for its rapid effects, offers symptom relief within hours or days. This relief period is much faster than traditional antidepressants, which can take weeks to work. The FDA’s decision was based on clinical trials that demonstrated significant improvements in patients using Spravato compared to a placebo.
Potential side effects of the drug include dizziness, dissociation and increased blood pressure, but these are typically temporary and manageable. As with any new treatment, patients should discuss risks and benefits with their healthcare provider. This approval is set to become a game-changer for patients as it provides a faster-acting option for managing their symptoms.
“We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal,” said Bill Martin, J&J’s global therapeutic area head of neuroscience, in an interview with CNBC.
