FDA Approves Verrica Phamaceuticals’ Ycanth™ for Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc., has announced that the U.S. Food and Drug Administration has approved Ycanth™ (cantharidin) topical solution for the treatment of molluscum contagiosum adult and pediatric patients 2 years of age and older.
Molluscum contagiosum is a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum contagiosum 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 wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum contagiosum can last for an average of 13 months, and in some cases, up to several years.
Ycanth is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator, allowing for precise topical dosing and targeted administration. Ycanth must be administered by a healthcare professional trained in its administration. Verrica plans to make Ycanth ™ available by September 2023.The approval is based on positive results from two identical Phase 3 randomized, double-blind, multicenter clinical trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102 (Ycanth) compared to a placebo in patients two years of age and older diagnosed with molluscum contagiosum.
There were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate.
