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Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum
Assigns PDUFA goal date of July 23, 2023 VP-102 (cantharidin 0.7% Topical Solution) could potentially be the first FDA-approved treatment for molluscum
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"Assigns PDUFA goal date of July 23, 2023 VP-102 (cantharidin 0.7% Topical Solution) could potentially be the first FDA-approved treatment for molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children WEST CHESTER, Pa., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s resubmitted New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (“molluscum”) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 23, 2023. “We are pleased that the FDA has accepted for filing our NDA resubmission for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “With no FDA-approved treatments for molluscum, the filing acceptance of our NDA brings us one step closer towards providing a safe and effective therapeutic treatment option for the millions of patients in the United States with molluscum. VP-102 has been designed for reliable and targeted administration of cantharidin through a unique, topical, GMP-controlled formulation through a single-use applicator. Based upon the strong safety and efficacy results from our two Phase 3 clinical trials, we believe that VP-102 has the potential to offer an important new treatment option for molluscum.” About VP-102 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 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. Verrica is seeking conditional approval to market VP-102 in the United States under the 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. About Molluscum Contagiosum (...