Verrica Pharmaceuticals announced 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.

Verrica?s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review and could potentially be the first product approved by the FDA to treat molluscum contagiosum ― a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH?. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.