Policy & Regulation
US FDA accepts Verrica Pharmaceuticals' New Drug Application for VP-102
29 November 2019 -

The United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for United States-based Verrica Pharmaceuticals Inc's (Nasdaq: VRCA), VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy intended for the treatment of contagious viral skin disease molluscum contagiosum (molluscum), it was reported yesterday.

The Prescription Drug User Fee Act (PUDFA) goal date assigned by the US FDA for this NDA is 13 July 2020.

The NDA is based on positive results from two identical Phase three randomised, double-blind, multicentre clinical trials (CAMP-1 and CAMP-2) that assessed the safety and efficacy of VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum. In both trials, a clinically and statistically significant number of patients treated with VP-102 met the primary endpoint of complete clearance of all treatable molluscum lesions.



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