Novel Treatment for Recurrent Vulvovaginal Candidiasis Gets Fast Track Status
Viamet has announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to VT-1161, a novel treatment for recurrent vulvovaginal candidiasis (RVVC).
There are currently no approved therapies in the U.S. for RVVC, or recurrent vaginal yeast infection, a common and difficult to treat condition. “The large number of women afflicted by this condition, combined with the lack of approved therapies, highlight the immense need for a safe and effective treatment for RVVC,” said Robert Schotzinger, MD, PhD, and CEO of Viamet. It is estimated that 5 to 8% of women of child-bearing age in the U.S. are affected by RVVC.
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51, which blocks the production of ergosterol, an essential component of the fungal cell membrane.
A Phase 2b test of VT-1161 for the oral treatment of RVVC and onychomycosis – a highly prevalent fungal infection of the nail – is nearing completion. In preclinical studies, VT-1161 has demonstrated broad-spectrum activity against both Candida and dermatophyte species.
For more information visit Viamet.com.