Drug updated on 4/17/2024
Dosage Form | Tablet (oral; 18.2 mg, 36.3 mg, 54.5 mg, 72.6 mg) |
Drug Class | Serotonin 5-HT1A receptor selective partial agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of major depressive disorder (MDD) in adults.
Summary
- Gepirone (Exxua) is recommended for the management of major depressive disorder (MDD) in adults and has been demonstrated to be more effective than placebo treatments according to a systematic review/meta-analysis.
- The analysis was based on systematic reviews/meta-analyses.
- In the aspect of effectiveness, 5-HT1A agonists like gepirone showed a significant increase in treatment response compared to placebo, with a number needed to treat (NNT) of 6. This finding was based on data from 15 randomized controlled trials involving a total of 2469 participants.
- However, augmentation therapy with these medications did not reveal statistically significant effects on response rates when compared with control treatments, as indicated by four augmentation trials comprising 365 participants.
- While these medications were favored for reducing discontinuation due to inefficacy, they were linked to a higher discontinuation rate because of side effects such as gastrointestinal symptoms, dizziness, insomnia, palpitations, paresthesia, and sweating, which may limit their tolerability.
- No specific population types or subgroup considerations beyond the general adult population suffering from MDD were identified in this study; additional research would be necessary to determine how different subgroups might react to or tolerate this medication's treatment.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Exxua (gepirone) Prescribing Information. | 2023 | Fabre-Kramer Pharmaceuticals Inc., Houston, TX |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Azapirone 5-HT1A receptor partial agonist treatment for major depressive disorder: systematic review and meta-analysis. | 2014 | Psychological Medicine |