Is Esketamine FDA-Approved?

SPRAVATO™, a branded version of esketamine, has FDA approval for TRD (Treatment Resistant Depression). It comes in the form of a nasal spray that the patient takes under a doctor’s direct supervision.

Johnson & Johnson submitted five Phase 3 studies on the drug: three-short term studies, one maintenance study, and a long-term safety study. Two of those turned up positive results. One was a randomized trial in adults under age 65 with treatment-resistant depression who were started on an oral antidepressant and intranasal esketamine. After a month, roughly 70% of patients who received the treatment responded compared to just over half in a placebo group. The researchers considered an improvement of 50% or more on a common depression rating scale as a successful response.

As a result of findings like these, the FDA approved SPRAVATO™ for supervised use in March 2019. Because of esketamine’s potential side effects, the FDA requires doctors to distribute SPRAVATO™ under the Risk Evaluation and Mitigation Strategy (REMS).

The SPRAVATO™ REMS (Risk Evaluation and Mitigation Strategy)

To protect patients, SPRAVATO™ treatment has the following measures in place:

• Patients may only receive and take SPRAVATO™ in a medically supervised setting
• Pharmacies and health care organizations that distribute SPRAVATO™ must have special certification
• Each patient receives detailed information on the potential severe side effects of SPRAVATO™
• Every SPRAVATO™ patient must enroll in a registry

What Are the Side Effects of Esketamine Nasal Spray?

During a SPRAVATO™ treatment session, the doctor monitors the patient for side effects after administration. These symptoms vary in severity, depending on the patient. The potential side effects of an esketamine treatment like SPRAVATO™ include:

• Dizziness
• Sedation
• Disassociation
• Anxiety
• Decreased sensitivity or feeling
• Lethargy
• Nausea and vomiting
• Feelings of impairment

What Are the Treatment Protocol and Dosage Recommendation for Esketamine?

A SPRAVATO™ treatment plan involves ongoing appointments where the patient self-administers the medicine. SPRAVATO™ comes in the form of a 28-milligram nasal spray device. Depending on how the patient reacts to the medication, they may take 56-milligram doses (two devices) or 84-milligram doses (three devices). For the first four weeks of treatment, the patient will visit twice a week for the induction phase, then once a week for the fifth to eighth weeks. After those first two phases, the doctor will recommend treatment once or twice a week.