FDA Approves Spravato (esketamine) for Treatment-Resistant Depression and Depressive Symptoms with Acute Suicidal Ideation in Adults

Spravato is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist.

Spravato is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established.

Administer SPRAVATO intranasally under the supervision of a healthcare provider. Assess blood pressure prior to and after administration. TRD: Evidence of therapeutic benefit should be evaluated at the end of the 4-week induction phase to determine need for continued treatment. Depressive symptoms in MDD with acute suicidal ideation or behavior: Evidence of therapeutic benefit should be evaluated after 4 weeks to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated. Recommended dosage for TRD: Induction phase (weeks 1 to 4): Administer twice per week at 56 mg or 84 mg. Maintenance phase (weeks 5 to 8): Administer once weekly at 56 mg or 84 mg. Week 9 and after: Administer every 2 weeks or once weekly at 56 mg or 84 mg, with dosing frequency individualized to maintain remission/response. Recommended dosage for depressive symptoms in MDD with acute suicidal ideation or behavior: 84 mg twice per week for 4 weeks, with possible reduction to 56 mg twice per week based on tolerability. Administration instructions: SPRAVATO must be administered under direct supervision of a healthcare provider, with monitoring for respiratory status for at least 2 hours per session. Assess blood pressure before dosing; do not administer if increase poses serious risk. Reassess blood pressure at approximately 40 minutes post-dose. Advise patients to avoid food for at least 2 hours before and liquids for at least 30 minutes before administration. If nasal corticosteroid or decongestant needed, administer at least 1 hour before SPRAVATO.

Trial data not available in label.

Not reported in label.

Not reported in label.