Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that its resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is June 23, 2021.
Verrica previously submitted an NDA for VP-102 for the treatment of molluscum in September 2019. As previously announced, the FDA issued a Complete Response Letter requesting additional Chemistry, Manufacturing and Controls (CMC) information as well as Human Factors validation in July 2020. Verrica resubmitted the NDA for VP-102 for the treatment of molluscum on December 23, 2020.
“This is an exciting time for Verrica as we work with the FDA to continue to move VP-102 through the regulatory process,” said Ted White, President and Chief Executive Officer, Verrica. “We believe that VP-102 is well-positioned to become the first FDA-approved product for the treatment of molluscum and could potentially bring relief to the millions of children diagnosed with this highly contagious disease.”
The NDA is based on positive results from two identical Phase 3 randomized, double-blind, multicenter clinical trials (CAMP-1 and CAMP-2) that evaluated 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.
VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102- treated subjects.