WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has announced that it received the minutes from its recent Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting, which took place on November 6, 2023, was focused on discussing the Phase 3 clinical development plan for YCANTH, a product currently approved only for treating molluscum contagiosum in adults and children aged two years and older.
The core objective of the meeting was to gain the FDA’s advice and consensus on the overall design of a pivotal Phase 3 study of YCANTH. The goal is for this study to support an efficacy supplement for the proposed indication of common warts.
Ted White, President & Chief Executive Officer of Verrica Pharmaceuticals, spoke positively about the outcome of the meeting. He stated, “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.”
The company views this as a significant step forward, given the potential market opportunity. Common warts affect over 20 million people in the U.S. annually, yet there are currently no FDA-approved products specifically for this condition. Based on the positive results from their Phase 2 studies, Verrica Pharmaceuticals sees YCANTH as having substantial potential to address this gap.
White added, “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.”
This development marks a crucial milestone in Verrica Pharmaceuticals’ journey to expand the applications of YCANTH. If the Phase 3 study is successful, it could potentially open up a new treatment avenue for millions of people affected by common warts, and provide an attractive growth opportunity for investors in Verrica Pharmaceuticals.
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