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Verrica Pharmaceuticals Announces Acceptance by FDA of NDA Resubmission for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, Pa., Dec. 15, 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., Dec. 15, 2021 (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) acknowledged that Verrica’s resubmitted New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) was complete and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022. “We are pleased that the FDA has accepted our NDA resubmission for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “While we recognize the demands of the Agency’s current workload, we intend to work with the FDA toward approval as quickly as possible based on the limited changes in our resubmission. We continue to be encouraged by the overwhelming demand from both caregivers and the medical community for an FDA-approved treatment for molluscum, one of the largest unmet needs in medical dermatology.” 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 — 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 we...