FDA Approves Intranasal Esketamine for Treatment-Resistant DepressionMarch 7, 2019
On March 5, 2019, the Food and Drug Administration (FDA) approved a new drug application for Spravato (esketamine; Janssen Pharmaceuticals Inc.) for the treatment of treatment-resistant depression in adults.
Spravato is a drug-device combination designed to deliver esketamine intranasally. Spravato is the s-enantiomer of ketamine, an FDA-approved general anesthetic agent. Of note, ketamine has been identified as a drug of abuse by the Drug Enforcement Agency (DEA); it is a Schedule III controlled substance under the Controlled Substances Act. Spravato has also been designated a Schedule III controlled substance, and may carry a risk of abuse and diversion.
Spravato will be available only via a Risk Evaluation and Mitigation Strategy (REMS), which requires the following:
- Healthcare settings must be certified in the program and ensure that Spravato is only dispensed in healthcare settings and administered to patients who are enrolled in the program;
- Spravato is administered by patients under the direct observation of a healthcare provider;
- Patients are monitored by a healthcare provider for at least 2 hours after administration of Spravato;
- Pharmacies must be certified in the REMS and must only dispense Spravato to healthcare settings that are certified in the program.
A Hayes Technology Prognosis Overview on Spravato is available here.
Food and Drug Administration (FDA). FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic [news release]. March 5, 2019. Available at: click here. Accessed March 7, 2019.