Date: 2012-08-08
Type of information:
phase: 3
Announcement: submission of an IND Investigational New Drug
Company: Ferrer (Spain)
Product: arasertaconazole nitrate
Action mechanism:
Disease: vulvovaginal candidiasis (VVC)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On August 8, 2012, Ferrer has announced that it has filed an IND for its topical antifungal agent arertaconazole nitrate.
The agent has recently demonstrated rapid symptomatic relief and significant clinical and mycological benefits after a single administration delivered as a vaginal suppository (pessary) formulation in a multicentre Phase II study in patients with VulvoVaginal Candidiasis (VVC). In the multicentre Phase II dose-ranging study involving 229 female patients with VVC, Arasertaconazole formulated as a vaginal suppository (pessary) demonstrated both fast-acting (superiority to placebo at 8 plus/minus 2 days of treatment) and prolonged (up to at least 26 plus/minus 4 days) clinical and mycological efficacy at all doses tested (150mg, 300mg, 600mg). The therapeutic response to Arasertaconazole was dose-dependent, with the 600mg dose most efficacious. Moreover, Arasertaconazole showed evidence of rapid relief from additional clinical symptoms (at less than 2 days, e.g. irritation and itching) when compared to placebo. Arasertaconazole was both safe and well tolerated in this study.
