Oteseconazole

(Vivjoa®)

Oteseconazole

Drug updated on 11/5/2024

Dosage FormCapsule (oral; 150 mg)
Drug ClassAzole antifungals
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

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Summary
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  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Oteseconazole significantly reduced the incidence of recurrent vulvovaginal candidiasis (RVVC) through week 48, with an odds ratio (OR) of 0.07 (95% Confidence Interval (CI): 0.05–0.11, p < 0.00001).
  • The incidence of RVVC was also significantly reduced by Oteseconazole through week 24, with an OR of 0.05 (95% CI: 0.03–0.09, p < 0.00001).
  • No specific population or subgroup findings were provided regarding differences in effectiveness.
  • Oteseconazole was non-significantly associated with developing serious adverse effects compared to placebo, with an Odds Ratio of 0.79 (95% CI: 0.33-1.89, p=0.60).
  • There were no significant safety concerns or adverse effects identified for Oteseconazole in the reviewed documents.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Vivjoa (oteseconazole) Prescribing Information.2024Mycovia Pharmaceuticals, Inc., Durham, NC

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines