VP 102 filed with FDA for molluscum contagiosum.- Verrica Pharma

Verrica Pharmaceuticals has submitted a New Drug Application (NDA) to the 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.

The 505(b)(1) NDA is supported by the positive results from two double-blind Phase III 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<0.0001). by the end of the trials (day 84), vp-102 treated subjects had a 69% and 83% mean reduction in molluscum lesions, a pre-specified endpoint, in camp-1 and camp-2, respectively, compared to a 20% increase and 19% reduction for subjects on placebo.>

VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects. Verrica has been granted a waiver by the FDA for the NDA application user fee under the small business waiver provision of the Federal Food, Drug and Cosmetic Act.