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– Two global Phase 3 VIOLET studies met key primary and secondary endpoints, authors conclude VIVJOA is highly effective in preventing recurrence of VVC for 48 weeks in participants with a history of VVC
– VIVJOA is now the only US Food and Drug Administration-approved option for postmenopausal and permanently infertile women with RVVC
DURHAM, NC–(BUSINESS WIRE)–Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering people living with unmet medical needs by developing new therapies, today announced the publication of positive Phase 3 data evaluating VIVJOA™ (oteseconazole) capsules in patients with recurrent vulvovaginal candidiasis (RVVC) in the July edition of NEJM Evidence, available here. VIVJOA is the first and only FDA-approved drug for RVVC indicated to reduce the incidence of RVVC in women with a history of RVVC who are NOT able to conceive.
Titled “Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis,” the article assessed the two worldwide, randomized, double-blind, placebo-controlled Phase 3 VIOLET studies of Mycovia, which included 656 women with RVVC who had experienced at least three symptomatic episodes of vulvo-vaginal. candidiasis (CVV) in the last 12 months. Of the 652 subjects whose presenting infections were cleared with fluconazole, 435 were randomly assigned to receive 150 mg of VIVJOA orally daily for seven days followed by once weekly for 11 weeks, and 217 were randomly assigned to a matching placebo for 12 weeks. Baseline demographics were similar in both trials.
Both VIOLET studies met their primary and secondary endpoints. At the end of the 48-week maintenance period, 93.3% and 96.1% of women with RVVC who received VIVJOA had no recurrence, compared to 57.2% and 60.6% of patients who received the placebo (P
Among the 22 women treated with VIVJOA who experienced an episode of VVC during the 48-week maintenance period, the average time to first recurrence of an episode of VVC was 45.7 and 47.2 weeks, versus 27.8 and 33.1 weeks for the 84 placebo-treated women who had a recurrence (PCandida cultures through week 48 compared to placebo groups (29.4% vs. 84.2% in the VIOLET 1 trial, PP
The types and frequencies of treatment-emergent adverse events (TEAEs) were similar between subjects receiving VIVJOA or placebo, with no drug-related serious TEAEs or adverse effects on liver function, QT interval, or pregnancy outcomes. Please see important safety information below.
The authors concluded that VIVJOA “was highly effective in preventing recurrence of VVC up to week 48 in participants with a history of RVVC, with potent activity against fluconazole resistants. C. albicans and C. glabrata species and mainly light TEAEs.
“Publication of VIOLET data in NEJM Evidence is important because VIVJOA has demonstrated notable efficacy as a treatment option for postmenopausal and permanently infertile women living with chronic yeast infection,” said Dr. Jack Sobel, co-lead author of the paper and professor Distinguished Fellow of Internal Medicine, Division of Infectious Diseases. , and Dean Emeritus of Wayne State University. “We seek to further evaluate and amplify the outcomes of treating appropriate RVVC patients with VIVJOA, which remains the only FDA-approved drug for this condition.”
About recurrent vulvovaginal candidiasis
RVVC is a chronic debilitating infectious disease that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a separate condition from vulvovaginal candidiasis (VVC) and defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months. The main symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful intercourse or urination, causing varying but often severe discomfort and pain.
VIVJOA™ (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in women with a history of RVVC who are NOT able to reproduce. VIVJOA is the first and only FDA-approved drug that provides sustained efficacy demonstrated by a significant long-term reduction in the recurrence of RVVC over 50 weeks compared to comparators. Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective interaction is also toxic to fungi, resulting in inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes than fungal CYP enzymes. The FDA approved VIVJOA based on positive results from three Phase 3 clinical trials of oteseconazole – two global VIOLET studies and a US-centric ultraVIOLET study, including 875 patients at 232 sites in 11 countries.
Please click here for complete prescribing information.
IMPORTANT SAFETY INFORMATION
VIVJOA is contraindicated in women of childbearing age. Women who are NOT able to procreate are defined as: people who are biological women who are postmenopausal or have another reason for permanent infertility (eg, tubal ligation, hysterectomy, salpingo-oophorectomy).
VIVJOA is contraindicated in pregnant and breastfeeding women.
VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Based on animal studies, VIVJOA can cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate risk mitigation for embryo-fetal toxicity. Advise patients that VIVJOA is contraindicated in women of childbearing potential and in pregnant and lactating women due to potential risks to the fetus or nursing infant.
The most commonly reported adverse reactions in patients treated with VIVJOA in clinical studies included headache (7.4%) and nausea (3.6%).
VIVJOA is a breast cancer resistance protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (eg, rosuvastatin) may increase exposure to BCRP substrates, which may increase the risk of adverse reactions associated with these drugs.
Please see full prescribing information and patient information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Mycovia Pharmaceuticals
Mycovia Pharmaceuticals is an emerging biopharmaceutical company dedicated to recognizing and empowering people living with unmet medical needs by developing new therapies. VIVJOA™ (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in women with a history of RVVC who are NOT able to procreate. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved treatment for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan, and Gedeon Richter Plc., a pharmaceutical company based in Hungary, to market and manufacture oteseconazole in Europe, Russia, the Commonwealth of Independent States, Latin America and Australia. Mycovia also recognizes enormous potential for its oral fungal inhibitors and a growing need to treat a range of multidrug-resistant fungal pathogens. For more information, visit www.mycovia.com.
Mycovia Pharmaceuticals, Inc.
Elizabeth Comtois, 919-334-3786
Source: Mycovia Pharmaceuticals, Inc.