FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression
Once Spravato is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs.
Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). This is the first new mechanism of action in 3 decades to treat major depressive disorder (MDD).1,2
The approval follows a phase 3 clinical trial with more than 1700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at 4 weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.
People who are currently struggling with MDD are considered to have TRD if they have not responded adequately to at least 2 different antidepressants of adequate dose and duration in the current depressive episode. It is estimated that approximately one-third of US adults with MDD have TRD.
Spravato carries a boxed warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.
In the clinical trials, the most common side effects of Spravato when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
Once Spravato is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs. The medication will not be dispensed directly to patients for home use. The health care provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least 2 hours, until the patient is safe to leave. Patients should not drive or operate heavy machinery until the next day, following a restful sleep. All patients will be enrolled in the Spravato REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine.
- Spravato [Prescribing Information]. Titusville, N.J., Janssen Pharmaceuticals, Inc.
- Johnson & Johnson Press Release. 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. https://www.janssen.com/janssen-announces-us-fda-approval-spravato-esketamine-ciii-nasal-spray-adults-treatment-resistant Accessed March 5, 2019.