Prime Highlights:
The FDA has approved Johnson & Johnson’s Spravato (esketamine) nasal spray for standalone use in treating severe depression.
Originally approved in 2019 as an adjunct to oral antidepressants, the new approval provides greater flexibility for healthcare providers in personalizing treatment plans.
Spravato works by targeting the neurotransmitter glutamate, although the exact mechanism of its antidepressant effect remains unclear.
Key Background:
The U.S. Food and Drug Administration (FDA) has expanded the approval of Johnson & Johnson’s nasal spray, Spravato, allowing its use as a standalone treatment for patients suffering from severe depression, the company announced on Tuesday. Initially approved in 2019, Spravato was first authorized for use in combination with traditional antidepressants. It was later approved for individuals with suicidal ideation or actions. This new approval provides healthcare providers with more flexibility to tailor treatment plans to the specific needs of patients.
Spravato, which is derived from ketamine, a substance that is also used as a recreational drug, works by targeting the neurotransmitter glutamate, which is vital for various brain functions. Esketamine, the active ingredient in Spravato, is a chemical mirror image of ketamine, and the exact mechanism by which it alleviates depression remains unclear. However, its rapid onset of action has made it a promising option for patients who have not responded to traditional oral antidepressants. The drug is only available through a restricted program due to the potential for misuse.
This approval follows a clinical study where patients treated with Spravato as a monotherapy demonstrated rapid and significant improvements in the severity of depressive episodes compared to those receiving a placebo. Over 20% of patients receiving the treatment achieved remission. This approval comes at a time when major depressive disorder (MDD) is one of the most prevalent mental health conditions in the United States, with approximately 21 million adults experiencing at least one depressive episode in 2021, according to government data.
The expanded approval of Spravato is expected to address a significant treatment gap, as roughly one-third of patients with MDD do not respond to conventional oral antidepressants. With Spravato’s new indication as a standalone treatment, healthcare providers can offer a more personalized approach to treating severe depression, enhancing the quality of care for those who need it most. For the first three quarters of 2024, Spravato generated $780 million in sales, underscoring its growing role in depression treatment.