This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
SUMMARY
- There are no studies evaluating the efficacy or safety of concurrent treatment with bupropion and SPRAVATO.
- In phase 3 clinical trials in patients with major depressive disorder and acute suicidal ideation or behavior, SPRAVATO was combined with standard-of-care (SOC) oral antidepressants (ADs), which was initiated or optimized with an AD alone or AD plus augmentation therapy.1,2 Therefore, patients may have been taking concomitant bupropion. However, no systematic evaluation of safety or efficacy was performed in that subset of patients.
- In a phase 1 study, esketamine (ESK) 84 mg administered twice weekly for 2 weeks, and oral bupropion administered at baseline and 24 hours after the last dose of ESK, did not affect the pharmacokinetics (PK) of bupropion.3
- SPRAVATO may increase blood pressure and require monitoring prior to initiating, and during, treatment.4
- Please contact the manufacturers of bupropion for more information regarding the safety and drug-drug interactions for this product that may cause or exacerbate adverse events.
CLINICAL DATA
Phase 1 Study with Bupropion
An open-label, multiple dose, parallel-group study was conducted to evaluate the PK, specifically the induction potential, of ESK on CYP2B6 activity using oral bupropion (a CYP2B6 substrate) in healthy subjects.3
- The bupropion cohort (n=13) received 150 mg oral bupropion on days 1 and 19 and ESK 84 mg on days 4, 7, 11, 14, and 18.
- The plasma and urinary PK of bupropion and its metabolite, hydroxybupropion, were not affected by multiple administrations of ESK.
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 08 April 2024.
1 | Fu DJ, Ionescu DF, Li X, et al. Supplement to: Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191. |
2 | Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22-31. |
3 | Data on File. Esketamine. Summary of Clinical Pharmacology. Janssen Research & Development, LLC. EMDS-ERI-149761559; 2018. |
4 | Data on File. Company Core Data Sheet - Esketamine - Version 08. Janssen Research & Development, LLC. EDMS-ERI-122750672; 2022. |