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Verrica Pharmaceuticals Announces Receipt of Minutes from Type C Meeting with FDA Regarding Clinical Development of YCANTH™ for the Treatment of Common Warts
WEST CHESTER, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"WEST CHESTER, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it received the minutes from the Company’s recent Type C meeting with the U.S. Food and Drug Administration (FDA), which was held on November 6, 2023, to discuss the Phase 3 clinical development plan for YCANTH for the treatment of common warts. More specifically, the Company believes that the Type C meeting satisfied its objective to gain the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts. YCANTH is currently only approved to treat molluscum contagiosum in adults and children two years of age and older. “We believe our recent Type C meeting with the FDA was highly productive and led to mutual alignment with respect to the design of a Phase 3 development plan to evaluate YCANTH for the treatment of common warts,” said Ted White, President & Chief Executive Officer of Verrica Pharmaceuticals. “Based upon positive results from our Phase 2 studies, we consider YCANTH to have significant potential to address this sizable market opportunity which affects over 20 million people in the U.S. annually with no FDA approved products. We remain focused on addressing some of the largest unmet needs in dermatology, and the successful outcome of this Type C meeting is an important step forward as we evaluate label expansion opportunities for YCANTH.” About YCANTH™ (formerly VP-102)YCANTH™ is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH™ is currently approved by the FDA to treat molluscum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Please visit YCANTHPro.com for additional information. 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. YCANTH™ should only b...