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Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, Pa., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"WEST CHESTER, Pa., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). The resubmission is limited to those sections and elements of the NDA that were identified as deficiencies in the Complete Response Letter (CRL) issued by the FDA in September 2021. The resubmission addresses the successful resolution of inspection deficiencies identified at a contract manufacturing organization (CMO) in the CRL, as well as the recommendations included in the General Advice Letter received from the FDA that relate to VP-102’s user interface. “We look forward to the FDA’s review of the resubmission of our NDA for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “Based on published guidance for the industry, we believe our resubmitted NDA qualifies as a Class I resubmission with a 2-month review. If approved, Verrica is well-prepared to launch VP-102 as the first FDA-approved treatment option for molluscum, a highly contagious viral skin disease affecting 6 million people, primarily children, in the U.S. each year.” 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. If approved, VP-102 would 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. VP-102 would 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. About Molluscum Contagiosum (Molluscum) There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children...