On January 21, 2025, the FDA announced a groundbreaking approval that could significantly expand treatment options for individuals suffering from treatment-resistant depression (TRD). Spravato (esketamine), a nasal spray developed by Janssen Pharmaceuticals, has now been approved as a monotherapy, marking a major milestone in psychiatry. Previously, Spravato was only allowed to be prescribed alongside an oral antidepressant medication. Since most people with TRD have already failed oral medications, the practice of a concomitant medication seemed unnecessary and burdensome for patients and providers alike.
What Is Spravato?
Spravato is a prescription nasal spray containing esketamine, a derivative of ketamine. Unlike conventional antidepressants, which primarily target serotonin, norepinephrine, or dopamine, esketamine works by modulating glutamate, a neurotransmitter involved in brain plasticity. This unique mechanism allows for rapid antidepressant effects, often noticeable within hours or days.
Initially approved in 2019 for use alongside oral antidepressants, Spravato’s effectiveness as an adjunctive therapy paved the way for further research into its potential as a stand-alone treatment.
Who Is Eligible for Spravato Monotherapy?
The new approval applies to adults diagnosed with TRD who have not responded to at least two prior antidepressant treatments. As with adjunctive Spravato therapy, patients must receive the medication in a certified treatment center under the supervision of a healthcare provider. This ensures safe administration and monitoring for potential side effects, such as sedation or dissociation.
Key Clinical Findings Behind the Approval
The FDA’s decision was based on robust clinical trials demonstrating Spravato’s efficacy and safety as a monotherapy. Key findings include:
Rapid Onset of Action: Patients reported significant symptom improvement within the first 24 to 48 hours.
Sustained Benefits: Long-term studies showed that regular treatment with Spravato led to sustained remission in many patients.
Manageable Side Effects: The most common side effects were dizziness, nausea, and dissociation, which were generally transient and mild.
Considerations for Patients and Providers
One of the benefits of Spravato is that insurance often covers it. So while it is a high-cost treatment without insurance, most people with insurance pay a copay of around $20 per appointment. Spravato remains a high-cost treatment, though insurance coverage has expanded in recent years. Patients are encouraged to work with their providers to navigate coverage options.
Patients should also be aware that it is only to be administered in-office, under medical supervision. Patients must agree to stay in the office for a minimum of two hours per appointment according to the REMS guidelines.
A New Era in Depression Treatment
The FDA’s approval of Spravato as a monotherapy is a monumental step forward in addressing treatment-resistant depression. It offers new hope for individuals who have struggled to find effective solutions and signals a growing commitment to innovative approaches in mental health care.
If you or a loved one is living with TRD, now may be the time to explore whether Spravato monotherapy is right for you. At Bespoke Treatment, we are committed to staying at the forefront of evidence-based care, offering cutting-edge therapies tailored to your needs. Contact us today to learn more or schedule a consultation.
