STEPS

New Drug Reviews

Esketamine (Spravato) for Treatment-Resistant Depression

 

Am Fam Physician. 2020 Mar 15;101(6):339-340.

Esketamine (Spravato) is an active isomer of ketamine that acts as an N-methyl-d-aspartate receptor antagonist.1,2 The exact antidepressant mechanism is unknown, but it is labeled as adjunctive therapy for adults with treatment-resistant depression who are already taking an oral antidepressant.

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DrugDosageDose formCost*

Esketamine (Spravato)

Single induction dose: 56 mg Induction phase (weeks 1 to 4): 56 or 84 mg twice per week Maintenance phase (weeks 5 to 8): 56 or 84 mg once weekly Maintenance phase (weeks 9 and beyond): 56 or 84 mg once weekly or every two weeks

Nasal spray

$5,000 to $7,500 for one-month induction phase $2,500 to $3,750 per month for maintenance phase


*—Estimated retail price for one month of treatment based on information obtained at https://www.drugs.com (accessed January 27, 2020).

DrugDosageDose formCost*

Esketamine (Spravato)

Single induction dose: 56 mg Induction phase (weeks 1 to 4): 56 or 84 mg twice per week Maintenance phase (weeks 5 to 8): 56 or 84 mg once weekly Maintenance phase (weeks 9 and beyond): 56 or 84 mg once weekly or every two weeks

Nasal spray

$5,000 to $7,500 for one-month induction phase $2,500 to $3,750 per month for maintenance phase


*—Estimated retail price for one month of treatment based on information obtained at https://www.drugs.com (accessed January 27, 2020).

Safety

Dissociation, in which a patient detaches from or becomes less aware of his or her surroundings, will occur in about 40% of patients who receive esketamine. More than one-half of patients will also experience sedation.1 Patients should be carefully observed for at least two hours after administration of esketamine and should not drive until the following day. The potential for abuse or diversion while taking esketamine is high, and the manufacturer suggests that caution be used in patients with a history of drug abuse or dependence. Esketamine should not be used in patients with a history of aneurysmal vascular disease, arteriovenous malformations, or intracerebral hemorrhage because it may cause a significant increase in blood pressure or intracranial pressure. Patients should have their blood pressure measured before and after administration. Esketamine should not be used in patients with severe hepatic impairment or in children or adolescents because these groups have not been studied.1,2 Esketamine has been shown to impair neuronal development when administered to pregnant or nursing animals, and it should not be used in pregnant or breastfeeding women.1

Tolerability

Adverse effects are common with esketamine. Dizziness, nausea, and vertigo occur in 20% to 30% of patients. Some will have hypoesthesia (18%) or anxiety (13%). Up to 17% will experience an increase of more than 40 mm Hg in systolic blood pressure and 25 mm Hg in diastolic blood pressure in the first 40 to 90 minutes after administration. The risk of an increase in blood pressure is higher in patients who are also taking monoamine oxidase inhibitors or stimulants. Patients should be referred for immediate emergency

Address correspondence to Mohamed Jalloh, PharmD, BCPS, at mohamed.jalloh@tu.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. DailyMed. Drug label information. Spravato—esketamine spray. Accessed October 25, 2019. https://dailymed.nlm.nih.gov/dailymed/...

2. U.S. Food and Drug Administration. 2019 meeting materials, Psychopharmacologic Drugs Advisory Committee. Accessed October 25, 2019. https://www.fda.gov/advisory-committees/psychopharmacologic-drugs-advisory-committee/2019-meeting-materials-psychopharmacologic-drugs-advisory-committee

3. Institute for Clinical and Economic Review. Esketamine for the treatment of treatment-resistant depression: effectiveness and value. Final evidence report. June 20, 2019. Accessed November 13, 2019. https://icer-review.org/wp-content/uploads/2018/10/ICER_TRD_Final_Evidence_Report_062019.pdf

4. Khan A, Khan SR, Shankles EB, et al. Relative sensitivity of the Montgomery-Åsberg Depression Rating Scale, the Hamilton Depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials. Int Clin Psychopharmacol. 2002;17(6):281–285.

5. Daly EJ, Trivedi MH, Janik A, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019;76(9):893–903.

6. Ross EL, Zivin K, Maixner DF. Cost-effectiveness of electro-convulsive therapy vs. pharmacotherapy/psychotherapy for treatment-resistant depression in the United States. JAMA Psychiatry. 2018;75(7):713–722.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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