Oteseconazole

Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China

Retrieved on: 
Wednesday, February 7, 2024
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DURHAM, N.C., Feb. 7, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has commercially launched VIVJOA® (oteseconazole) in China, making available an innovative oral azole antifungal indicated for the treatment of severe vulvovaginal candidiasis (VVC). VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.

Key Points: 
  • VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.
  • "The disease burden in China is significant, and access to VIVJOA provides health care providers and women suffering with severe VVC a new treatment option."
  • Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts.
  • In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules as the first medication for Recurrent Vulvovaginal Candidiasis (RVVC, or chronic yeast infection).

Mycovia Pharmaceuticals Announces Completion of Partner Jiangsu Hengrui Pharmaceuticals’ Phase 3 Clinical Study Evaluating Oteseconazole for Treatment of Acute Vulvovaginal Candidiasis (VVC) in China

Retrieved on: 
Wednesday, November 3, 2021
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Mycovia Pharmaceuticals, Inc. (Mycovia) today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd (Hengrui) has completed its Phase 3 clinical study of oteseconazole (SHR8008) compared to fluconazole in subjects with acute vulvovaginal candidiasis (VVC).

Key Points: 
  • Mycovia Pharmaceuticals, Inc. (Mycovia) today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd (Hengrui) has completed its Phase 3 clinical study of oteseconazole (SHR8008) compared to fluconazole in subjects with acute vulvovaginal candidiasis (VVC).
  • The last subject completed her final visit on Sept. 30, 2021, and data will support an NDA in China for oteseconazole.
  • Additionally, enrollment is underway for Hengruis randomized, double-blind, double-dummy, parallel group, fluconazole-controlled, multicenter Phase 3 clinical study named SHR8008-301.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Mycovia Pharmaceuticals Announces Presentation of Oteseconazole (VT-1161) Phase 3 Data Demonstrating Safety and Efficacy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) at the 2021 IDSOG Annual Meeting

Retrieved on: 
Thursday, July 29, 2021
Women, Biotechnology, Pharmaceutical, General Health, Health, FDA, Consumer, Clinical trials, Health sciences, Life sciences, Drug discovery, Health policy, Medicinal chemistry, Therapy, Food and Drug Administration, Ibrexafungerp, Mycovia Pharmaceuticals, Oteseconazole, Recurrent Vulvovaginal Candidiasis, NovaQuest Capital Management, MYCOVIA PHARMACEUTICALS, OTESECONAZOLE, RECURRENT VULVOVAGINAL CANDIDIASIS, NOVAQUEST CAPITAL MANAGEMENT

Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.

Key Points: 
  • Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.
  • This meeting provides a chance to generate increased discussion with healthcare professionals about RVVC and the need for improved treatment options.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).
  • Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations and, if approved, could be the first FDA-approved treatment for RVVC.

Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis  

Retrieved on: 
Wednesday, July 28, 2021
Women, Biotechnology, Pharmaceutical, Health, FDA, Infectious diseases, Consumer, Clinical trials, Food and Drug Administration, Pharmaceuticals policy, Prescription Drug User Fee Act, Health, Pharmaceutical industry, Regulation, PDUFA date, Mycovia Pharmaceuticals, Oteseconazole, Recurrent Vulvovaginal Candidiasis, NovaQuest Capital Management, MYCOVIA PHARMACEUTICALS, OTESECONAZOLE, RECURRENT VULVOVAGINAL CANDIDIASIS, NOVAQUEST CAPITAL MANAGEMENT

Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.
  • Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.
  • With this timeline and pending full FDA review and approval, Mycovia is preparing for a U.S. launch of oteseconazole in early 2022.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Mycovia Pharmaceuticals Announces Positive Topline Results from its Third Phase 3 Clinical Trial (ultraVIOLET) of Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis

Retrieved on: 
Wednesday, January 6, 2021
Research, Women, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Consumer, Health, Science, Health sciences, Health, Drugs, Clinical research, Drug discovery, Pharmaceutical industry, Design of experiments, Candidiasis, Vaginal yeast infection, Clinical trial, Fluconazole, Mycovia Pharmaceuticals, Oteseconazole, Recurrent Vulvovaginal Candidiasis

The study also compared the efficacy of oteseconazole and fluconazole in the treatment of acute VVC episodes.

Key Points: 
  • The study also compared the efficacy of oteseconazole and fluconazole in the treatment of acute VVC episodes.
  • The results from ultraVIOLET demonstrate oteseconazoles effectiveness in treating acute episodes and reinforce its efficacy and safety profile in treating RVVC.
  • Oteseconazole is currently in Phase 3 clinical trials designed to establish its safety and efficacy in RVVC patients.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy in late-stage clinical development for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Mycovia Pharmaceuticals Announces Positive Topline Results from Phase 3 VIOLET Studies of Oteseconazole in Patients with Recurrent Vulvovaginal Candidiasis

Retrieved on: 
Wednesday, December 9, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Health sciences, Life sciences, Animal diseases, Candidiasis, Vaginal yeast infection, Therapy, VVC, Medication, Cándida, Mycovia Pharmaceuticals, Oteseconazole, Recurrent Vulvovaginal Candidiasis

Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced positive topline results from its two pivotal Phase 3 VIOLET clinical trials for oteseconazole, its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC).

Key Points: 
  • Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced positive topline results from its two pivotal Phase 3 VIOLET clinical trials for oteseconazole, its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC).
  • Mycovia is at the vanguard for these women as we bring forward an innovative therapy in oteseconazole to address this significant unmet need.
  • Oteseconazole also protected greater than 90% of participants from having a recurrence during the maintenance phase.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy in late-stage clinical development for the treatment of recurrent vulvovaginal candidiasis (RVVC).