Business
Verrica Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for VP-102 for the Treatment of Molluscum Contagiosum
No FDA-approved treatments are currently available for this highly contagious, primarily pediatric, viral skin infection affecting an estimated 6 million
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"No FDA-approved treatments are currently available for this highly contagious, primarily pediatric, viral skin infection affecting an estimated 6 million people in the United States\nWEST CHESTER, Pa., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy, for the treatment of molluscum contagiosum (molluscum). No FDA-approved treatments are currently available for molluscum, a common, highly contagious skin disease affecting an estimated 6 million people in the United States, primarily children. Without treatment, molluscum can persist for an average of 13 months, with some cases remaining unresolved for several years.\n “Molluscum is a viral skin infection that is highly contagious, spreads rapidly, and is significantly undertreated, with no FDA-approved therapeutic options,” said Ted White, President and Chief Executive Officer, Verrica. “The NDA submission potentially brings us one step closer to our goal of providing patients — particularly children and their caregivers — with a safe and effective therapy for molluscum with our proprietary single-use applicator. If approved, VP-102 has the potential to become the standard of care for this disease.” The 505(b)(1) NDA is supported by the positive results from two double-blind Phase 3 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. The CAMP-1 and CAMP-2 studies enrolled 528 patients in total and were conducted at 31 centers in the United States. Each trial demonstrated superior efficacy of VP-102 compared to placebo with statistically significant differences on the primary endpoint of complete clearance of all treatable molluscum lesions. Specific results from CAMP-1 and CAMP-2 demonstrated 46% and 54%, respectively, of subjects treated with VP-102 achieved complete clearance at day 84, versus 18% and 13% of subjects in the placebo groups (p","length":2694,"tagName":"div"}]