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The Food and Drug Administration (FDA) has approved Vivjoa (oteseconazole) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.
Vivjoa is a novel oral inhibitor of fungal CYP51. The approval was based on data from three phase 3 trials, including 2 global studies (VIOLET: Trial 1; ClinicalTrials.gov Identifier: NCT03562156 and Trial 2; ClinicalTrials.gov Identifier: NCT03561701) and a US-focused study (ultraVIOLET; ClinicalTrials.gov Identifier: NCT03840616).
The studies evaluated the efficacy and safety of Vivjoa for the treatment of RVVC in female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months. Although females of reproductive potential were included in the clinical efficacy data, Vivjoa is contraindicated in females of reproductive potential due to the risk of embryo-fetal toxicity.
Trials 1 and 2 both consisted of an open-label induction phase in which patients received 3 sequential doses of fluconazole 150mg (every 72 hours) on days 1, 4, and 7. They then returned 14 days after the first fluconazole dose and if the acute VVC episode was resolved were randomly assigned to receive either Vivjoa 150mg or placebo for 7 days followed by 11 weekly doses in the maintenance phase.
Results from Trials 1 and 2 showed that 93.3% and 96.1% of patients who received Vivjoa did not have a recurrence for the 48-week maintenance period compared with 57.2% and 60.6% of patients who received placebo (P <.001).
In the randomized, double-blind ultraVIOLET study, patients received Vivjoa 1050mg over 2 days (600mg on day 1 and 450mg on day 2) or 3 sequential doses of fluconazole 150mg on days 1, 4, and 7. They then returned 14 days after the first dose and moved to the maintenance phase if the acute VVC episode was resolved. During the maintenance phase, patients received either Vivjoa 150mg or placebo weekly for 11 weeks.
Findings showed that 89.7% of patients who received Vivjoa cleared their initial infection and did not have a recurrence for the 50-week maintenance period compared with 57.1% of those who received fluconazole followed by placebo (P <.001)
The most common adverse reactions reported with Vivjoa were headache and nausea.
There are 2 recommended Vivjoa dosage regimens: a Vivjoa-only regimen and a fluconazole/ Vivjoa regimen. Vivjoa is supplied in an 18-count blister package and will be available in the second quarter of 2022.
References
- FDA approves Mycovia Pharmaceuticals’ Vivjoa™ (oteseconazole), the first and only fda-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). News release. Mycovia Pharmaceuticals, Inc. Accessed April 28, 2022. https://www.businesswire.com/news/home/20220428005301/en/FDA-Approves-Mycovia-Pharmaceuticals%E2%80%99-VIVJOA%E2%84%A2-oteseconazole-the-First-and-Only-FDA-Approved-Medication-for-Recurrent-Vulvovaginal-Candidiasis-Chronic-Yeast-Infection
- Vivjoa. Package insert. Mycovia Pharmaceuticals, Inc.; 2022. Accessed April 28, 2022. http://mycovia.com/wp-content/uploads/2022/04/VIVJOA-Full-Prescribing-Information.pdf
