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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.
宾夕法尼亚州西切斯特,2024年1月4日(环球通讯社)--Verrica Pharmaceuticals Inc.(“Verrica”或“该公司”)(纳斯达克:VRCA),一家皮肤病治疗公司,开发需要医疗干预的皮肤病药物,今天宣布收到该公司最近与美国。
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.
食品和药物管理局(FDA)于2023年11月6日举行会议,讨论YCANTH治疗寻常疣的3期临床开发计划。更具体地说,该公司认为,C型会议满足了其目标,即获得FDA关于YCANTH关键性3期研究总体设计的建议和协议,该研究将支持针对常见疣的拟议适应症的功效补充。
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.
YCANTH目前仅被批准用于治疗成人和两岁及以上儿童的传染性软体动物。Verrica Pharmaceuticals总裁兼首席执行官特德·怀特(TedWhite)表示:“我们认为,我们最近与FDA的C型会议取得了丰硕成果,并导致了在设计第三阶段发展计划方面的相互协调,以评估YCANTH治疗寻常疣的效果。”。
“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 .
“根据我们第二阶段研究的积极结果,我们认为YCANTH有很大的潜力来解决这个巨大的市场机会,这个市场机会每年影响美国2000多万人,没有FDA批准的产品。我们仍然专注于解决皮肤病学中一些最大的未满足需求,这次C型会议的成功结果是向前迈出的重要一步我们评估YCANTH的标签扩展机会。”关于YCANTH™ (原VP-102)YCANTH™ 是一种专有的药物-器械组合产品,含有通过GMP控制的斑蝥素制剂。