of women with RVVC who received a 12-week course of therapy with VIVJOA did NOT have a recurrence for nearly a year (48 weeks).
FINALLY,
the first FDA-approved medication for women living with chronic yeast infection known as recurrent vulvovaginal candidiasis (RVVC) who are postmenopausal or permanently infertile.1
FINALLY, the first FDA-approved medication for women living with chronic yeast infection known as recurrent vulvovaginal candidiasis (RVVC)who are postmenopausal or permanently infertile.1
With VIVJOA (oteseconazole), just one 12-week course of oral therapy provides nearly a year without recurrent yeast infections.1
- The first FDA-approved medication to reduce the incidence of RVVC as a unique azole antifungal that inhibits fungal growth.1-4
- VIVJOA delivers sustained efficacy demonstrated by long-term reduction of RVVC recurrence for nearly a year.1
Primary Efficacy Endpoints of Three Studies1
In three randomized, double-blind, placebo-controlled, phase 3 studies,
of patients who received placebo (P < .001).
Study 1 and 2 Conclusions (Global Studies)
VIVJOA effectively reduced RVVC recurrence in patients with a history of RVVC through Week 48.
VIVJOA oral dosing was statistically superior (P < .001) to placebo in reducing culture-verified acute VVC infections through Week 48.
VIVJOA demonstrated potent activity against Candida spp. including typically azole-resistant Candida glabrata.9
Study 3 Conclusions (US-based Study)
of women with RVVC who received a 12-week course of therapy with VIVJOA did NOT have a recurrence for nearly a year (50 weeks)
VIVJOA demonstrated potent activity against Candida spp. including typically azole-resistant Candida glabrata.9
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 phase.10
*ITT Population includes all subjects randomly assigned to receive study drug.
VIVJOA was safe and well tolerated in
580 PATIENTS
across three phase 3 clinical trials.1
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
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.
REFERENCES: 1. VIVJOA (oteseconazole). Prescribing Information. Mycovia Pharmaceuticals, Inc.; 4/2022. 2. Warrilow AGS, Hull CM, Parker JE, et al. The clinical candidate VT-1161 is a highly potent inhibitor of Candida albicans CYP51 but fails to bind the human enzyme. Antimicrob Agents Chemother. 2014;58(12):7121-7127. 3. Schell WA, Jones AM, Garvey EP, Joekstra WJ, Schotzinger RJ, Alexander BD. Fungal CYP51 inhibitors VT-1161 and VT-1129 exhibit strong in vitro activity against Candida glabrata and C. krusei isolates clinically resistant to azole and echinocandin antifungal compounds. Antimicrob Agents Chemother. 2017;61(3):e01817-16. 4. Sobel JD, Nyirjesy P. Oteseconazole: an advance in treatment of recurrent vulvovaginal candidiasis. Future Microbiol. 2021;16(18):1453-1461. 5. Jaeger M, Plantinga TS, Joosten LA, Kullberg BJ, Netea MG. Genetic basis for recurrent vulvo-vaginal candidiasis. Curr Infect Dis Rep. 2013;15(2):136-42. 6. Peters BM, Yano J, Noverr MC, Fidel PL Jr, et al. Candida vaginitis: when opportunism knocks, the host responds. PLoS Pathog. 2014;10(4):e1003965. 7. Sobel, SD. Recurrent vulvovaginal candidiasis. Am J Obstet Gynecol. 2016;214(1):15-21. 8.Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep.2021;70(4):1-187. 9. Sobel JD, Donders G, Degenhardt T, Person K, et al. Efficacy and safety of oteseconazole in recurrent vulvovaginal candidiasis. NEJM Evid. 2022;1(8):1-13. 10. Martens MG, Maximos B, Degenhardt T, Person K, et al. Phase 3 study evaluating the safety and efficacy of oteseconazole in the treatment of recurrent vulvovaginal candidiasis and acute vulvovaginal candidiasis infections. Am J Obstet Gynecol. 2022;19:S0002-9378(22)00577-4. 11. Ghannoum M, Degenhardt TP, Person KL, Brand SR. Susceptibility Testing of Oteseconazole (VT 1161), Against Clinical Isolates from Phase 5 Clinical Studies in Subjects with Recurrent Vulvovaginal Candidiasis. Poster presented at Infectious Disease Week; 2021 9/29-10/3. Virtual Conference. [Abstract 719].