Johnson & Johnson’s Spravato has received a significant boost to its potential as a blockbuster drug after the FDA granted it approval as a monotherapy treatment for major depressive disorder (MDD). Initially approved in 2019, Spravato was initially restricted to use with an oral antidepressant. However, this new endorsement allows patients to use the nasal spray alone.
The approval is based on results from a trial that showed significant improvements over placebo in all 10 categories of the Montgomery-Asberg Depression Rating Scale (MADRS). After 28 days, patients taking Spravato achieved remission at a rate of 22.5%, compared to 7.6% for those in the placebo group.
Spravato’s manufacturer, J&J, notes that treatment-resistant depression can be particularly challenging for patients who cannot take oral antidepressants or experience limited symptom improvement. The new label expansion offers healthcare providers a much-needed option to improve symptoms.
The approval comes with restrictions due to concerns over potential misuse and its regulation through the Risk Evaluation and Mitigation Strategy program. Despite these limitations, Spravato’s sales have surged, reaching $780 million in the first three quarters of 2024 – a 62% increase from the same period in 2023.
Source: https://www.fiercepharma.com/pharma/johnson-johnsons-spravato-gains-fda-nod-be-used-monotherapy