Vivjoa™ (oteseconazole) is now available to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. Females who are not of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (eg, tubal ligation, hysterectomy, salpingo-oophorectomy).
Vivjoa is a novel oral inhibitor of fungal CYP51. 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 with at least 3 episodes of acute VVC in the past 12 months. Findings from these studies showed treatment with a 12-week course of Vivjoa resulted in significant long-term reduction of RVVC recurrence for up to 50 weeks.
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. 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 as a 150mg capsule of oteseconazole in an 18-count blister package; fluconazole is not supplied in the carton.
Mycovia Pharmaceuticals is providing a patient support program (My Vivjoa) through vitaCare to help eligible patients receive treatment.
- Mycovia Pharmaceuticals announces US availability of Vivjoa™ (oteseconazole) capsules, the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). News release. Mycovia Pharmaceuticals, Inc. Accessed July 18, 2022. https://www.businesswire.com/news/home/20220718005049/en/Mycovia-Pharmaceuticals-Announces-U.S.-Availability-of-VIVJOA%E2%84%A2-oteseconazole-Capsules-the-First-and-Only-FDA-Approved-Medication-for-Recurrent-Vulvovaginal-Candidiasis-Chronic-Yeast-Infection
- Vivjoa. Package insert. Mycovia Pharmaceuticals, Inc.; 2022. Accessed July 18, 2022. http://mycovia.com/wp-content/uploads/2022/04/VIVJOA-Full-Prescribing-Information.pdf