Gepirone

(Exxua®)

Exxua®

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Drug updated on 4/17/2024

Dosage FormTablet (oral; 18.2 mg, 36.3 mg, 54.5 mg, 72.6 mg)
Drug ClassSerotonin 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
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  • 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 TitleYearSource
Exxua (gepirone) Prescribing Information.2023Fabre-Kramer Pharmaceuticals Inc., Houston, TX

Systematic Reviews / Meta-Analyses