Spravato Clinical Studies
The Most Significant New Depression Treatment in Decades
SPRAVATO™ Clinical Trials
SPRAVATO™ is a paradigm-changing medication recently approved by the FDA to treat depression. Spravato™ is the first intranasal therapy derived from esketamine and approved for treating depression and major mood disorder treatment-resistant depression (TRD) in adults. TRD affects 2.8 million Americans or 1.1% of the U.S. population.
SPRAVATO™ Clinical Trial Results
SPRAVATO™ is a rapid onset, nasally administered anti-depressant derived from esketamine. Recent studies show that patients given SPRAVATO™, combined with oral anti-depressants, demonstrated significant improvement in their depression symptoms over four weeks. Some patients experienced symptom relief in as little as four hours.
Patients taking SPRAVATO™ showed superior improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) versus patients given only oral anti-depressants. These patients demonstrated a 19.8 MADRS scale reduction in depression symptoms after four weeks. This MADRS scale reduction was nearly five points higher than that with oral anti-depressants only treatment.
Furthermore, patients achieved stable symptom remission over a long-term period with SPRAVATO™ and oral anti-depressant maintenance treatments. Compared with patients taking only oral anti-depressants, SPRAVATO™ patients were 56% less likely to experience symptom relapse.
- US Food and Drug Administration. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic. March 6, 2019. www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified. Accessed May 31, 2019.
- Janssen Pharmaceuticals. Janssen announces U.S. FDA approval of Spravato (esketamine) CIII nasal spray for adults with treatment-resistant depression (TRD) who have cycled through multiple treatments without relief. March 5, 2019. www.janssen.com/janssen-announces-us-fda-approval-spravato-esketamine-ciii-nasal-spray-adults-treatment-resistant. Accessed May 31, 2019.
- Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010;35:192-216.
- ClinicalTrials.gov. A study to evaluate the efficacy, safety, and tolerability of flexible doses of intranasal esketamine plus an oral antidepressant in adult participants with treatment-resistant depression (TRANSFORM-2). https://clinicaltrials.gov/ct2/show/NCT02418585. Accessed June 5, 2019.
- ClinicalTrials.gov. A study of intranasal esketamine plus an oral antidepressant for relapse prevention in adult participants with treatment-resistant depression (SUSTAIN-1). https://clinicaltrials.gov/ct2/show/NCT02493868. Accessed June 5, 2019.