THE VIVJOA DIFFERENCE
12-week course of therapy and nearly a year without recurrence1
In 2 randomized, double-blind, placebo - controlled, global phase 3 studies,
(P < .001).1
GLOBAL STUDIES DESIGN2
Women with three or more symptomatic acute vulvovaginal candidiasis (VVC) episodes within the previous 12-month period, including the screening episode (in which the VVC episode cleared with fluconazole induction therapy), were randomly assigned 2:1 at baseline (maintenance phase) to 150 mg of oral VIVJOA daily for 7 days followed by once weekly for 11 weeks, or to matching placebo for 12 weeks. Participants were followed for an additional 36 weeks without treatment, for a total of 48 weeks.
PRIMARY EFFICACY OUTCOME MEASURE
Proportion of subjects with 1 or more culture-verified acute VVC episodes during the Maintenance Phase in the Intent-to-Treat (ITT) Population.*
ITT POPULATION
Trial 1
VIVJOA n = 217
Placebo n = 109
Trial 2
VIVJOA n = 218
Placebo n = 108
GLOBAL STUDIES CONCLUSIONS
- VIVJOA effectively reduced RVVC recurrence in patients with a history of RVVC through Week 481
- VIVJOA oral dosing was statistically superior (P < .001) to placebo in reducing culture-verified acute VVC infections through Week 481
- VIVJOA demonstrated potent activity against Candida spp. including typically azole-resistant Candida glabrata2
In a single, randomized, double-blind, placebo-controlled, US-focused phase 3 study,
US-BASED STUDY DESIGN3
Women with a history of RVVC and presenting with an active vulvovaginal candidiasis infection were randomly assigned 2:1 in the induction phase to receive 600 mg of oral VIVJOA on day 1 and 450 mg on day 2, with matching placebo capsules, or to 3 sequential 150-mg oral doses (once every 72 hours) of fluconazole, with matching placebo capsules. Following the 2-week induction phase, the participants with resolved acute vulvovaginal candidiasis infection entered the maintenance phase and received 150 mg of VIVJOA or placebo weekly for 11 weeks. Both groups were then followed for 37 weeks without treatment, for a total of 50 weeks.
PRIMARY EFFICACY OUTCOME MEASURE
Proportion of subjects with 1 or more culture verified acute VVC episodes (post-randomization through Week 50) in the Intent-to-Treat (ITT) Population.*
ITT POPULATION
VIVJOA n = 147
Fluconazole/Placebo n = 72
US-BASED STUDY CONCLUSIONS
- VIVJOA effectively reduced RVVC recurrence in patients with a history of RVVC for nearly a year (50 weeks)1
- VIVJOA was superior when compared with fluconazole/placebo in the proportion of patients ≥ 1 culture-verified recurring acute VVC episodes during the maintenance phase (post randomized through Week 50) or failed clearing their infection during the induction phase1
- VIVJOA demonstrated potent activity against Candida spp. including typically azole-resistant Candida glabrata3
VIVJOA was safe and well tolerated in more than
Overall, similar percentages of serious adverse reactions were reported for patients receiving VIVJOA or comparator.1
The most frequently reported adverse reactions among patients treated with VIVJOA in all phase 3 clinical studies included headache (7.4%) and nausea (3.6%)1
Learn About the VIVJOA Mechanism of Action Designed for Recurrent Vulvovaginal Candidiasis (RVVC)
INDICATION
VIVJOA® (oteseconazole) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Females of Reproductive Potential: VIVJOA is contraindicated in females 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 (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).
Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.
Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
ADVERSE REACTIONS
The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).
DRUG INTERACTIONS
Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. In addition, the drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks.
Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data.
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.
Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.
Geriatric Use: Clinical studies of VIVJOA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Renal Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.
Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.
Please see full Prescribing Information and Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATION
VIVJOA® (oteseconazole) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Females of Reproductive Potential: VIVJOA is contraindicated in females 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 (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).
Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.
Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
ADVERSE REACTIONS
The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).
DRUG INTERACTIONS
Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. In addition, the drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks.
Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data.
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.
Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.
Geriatric Use: Clinical studies of VIVJOA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Renal Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.
Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.
Please see full Prescribing Information and Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.