The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for oteseconazole for the treatment of recurrent vulvovaginal candidiasis (VVC).
Oteseconazole is a novel oral inhibitor of fungal CYP51. The NDA submission is supported by data from three phase 3 trials, including 2 global studies (VIOLET; ClinicalTrials.gov Identifier: NCT03562156, NCT03561701) and a US-focused study (ultraVIOLET; ClinicalTrials.gov Identifier: NCT03840616). The studies evaluated the efficacy and safety of oteseconazole for the treatment of recurrent VVC in female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months.
Results from the VIOLET studies demonstrated that oteseconazole met the primary endpoint (recurrence rate; P <.001) and key secondary endpoints. Combined phase 3 data showed that oteseconazole prevented a recurring episode of VVC in more than 90% of patients for approximately 1 year. Moreover, in the ultraVIOLET study, oteseconazole was found to be noninferior to fluconazole in the resolution of signs and symptoms at day 14.
“Research shows that fluconazole, the standard of care for VVC, is more than 90% effective in treating an initial episode of VVC, but in studies of patients with [recurrent VVC], greater than 50% of women experience a recurrence following maintenance therapy discontinuation,” said Patrick Jordan, CEO of Mycovia Pharmaceuticals. “We designed oteseconazole to address this need as a highly selective targeted oral therapy that demonstrates improved efficacy with fewer side effects than current treatment options, including fluconazole.”
A Prescription Drug User Fee Act (PDUFA) target date of January 27, 2022 has been set for the application.
- Mycovia Pharmaceuticals announces US FDA acceptance and Priority Review of New Drug Application for oteseconazole for the treatment of recurrent vulvovaginal candidiasis. News release. Mycovia Pharmaceuticals, Inc. Accessed July 28, 2021. https://www.businesswire.com/news/home/20210728005166/en/Mycovia-Pharmaceuticals-Announces-U.S.-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Oteseconazole-for-the-Treatment-of-Recurrent-Vulvovaginal-Candidiasis-%C2%A0.
- Mycovia Pharmaceuticals announces positive topline results from its third phase 3 clinical trial (ultraVIOLET) of oteseconazole for the treatment of recurrent vulvovaginal candidiasis. News release. Mycovia Pharmaceuticals, Inc. January 6, 2021. Accessed July 28, 2021. https://static1.squarespace.com/static/5ab958c5e749401d7a2ed988/t/5ff4977a2ab9006c440f985c/1609865082913/Mycovia+Oteseconazole+ultraVIOLET+Topline+release_FINAL_1.5.21.pdf.
This article originally appeared on MPR