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FDA approved Spravato (esketamine) for Treatment-Resistant Depression and Depressive Symptoms with Acute Suicidal Ideation in AdultsThe FDA approved a new nasal spray called Spravato for severe depression

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Key Takeaway
Consider Spravato for TRD or MDD with acute suicidal ideation under supervised administration with monitoring.

The FDA has approved Spravato (esketamine) for two indications in adults: treatment-resistant depression (TRD) as monotherapy or with an oral antidepressant, and depressive symptoms in major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. This approval provides a new option for clinicians managing severe depression cases, particularly where traditional therapies have failed or in acute settings with suicidal risk. Spravato is a non-competitive NMDA receptor antagonist administered intranasally under direct healthcare supervision, requiring careful monitoring due to potential effects on blood pressure and respiratory status. The label notes that its effectiveness in preventing suicide or reducing suicidal ideation has not been demonstrated, and hospitalization may still be warranted despite initial improvement.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The FDA has approved a new medication called Spravato for treating severe depression in adults. This nasal spray is specifically for two situations: when depression hasn't improved with other treatments, and when someone with depression is experiencing serious suicidal thoughts or behaviors. It's designed to be used alongside other depression medications and is given under direct medical supervision.

This approval means doctors now have another tool to help people with particularly difficult cases of depression. For those who haven't found relief with traditional treatments, or who are in crisis with suicidal thoughts, this represents a new option that wasn't previously available.

It's important to understand that while this medication can help with depressive symptoms, the FDA notes that it hasn't been shown to prevent suicide or reduce suicidal thoughts. People receiving this treatment need careful monitoring because it can affect blood pressure and breathing.

If you or someone you know is dealing with severe depression, the most important step is to talk with a healthcare provider about all available treatment options. Only a doctor who knows your specific situation can determine if this or any other treatment might be appropriate.

What this means for you:
This new nasal spray offers another option for severe depression, but patients should discuss all treatments with their doctor.

Study Details

Study typeFda approval
PublishedMar 2019
View Original Abstract ↓
1 INDICATIONS AND USAGE 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 SPRAVATO is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated for the treatment of: Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant. ( 1 ) Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. ( 1 ) 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. ( 1 ) SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. ( 1 ) Limitations of Use The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated [see Clinical Studies (14.2) ] . 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.
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