– Molluscum, is a highly contagious viral skin infection affecting approximately 6 million people annually in the United States, primarily children –
– YCANTH™ is a drug-device combination product administered by a healthcare professional; Verrica plans to make YCANTH™ available by September 2023
– Verrica to host investor conference call and webcast Monday at 8:30 a.m. ET –
WEST CHESTER, Pa., July 21, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced U.S. Food and Drug Administration (FDA) approval of YCANTH™ (cantharidin) topical solution for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients 2 years of age and older.
“We are proud to bring patients and caregivers the first FDA-approved treatment for molluscum, which is one of the largest unmet needs in medical dermatology,” commented Ted White, Verrica’s President and Chief Executive Officer. “Verrica is the first company to develop a proprietary applicator and GMP-formulation of cantharidin that allows a safe, effective and precise topical administration, and the first company to successfully gain FDA approval after conducting rigorous clinical trials to evaluate the safe and effective use of a cantharidin-based product for the treatment of molluscum. We wish to express our gratitude to the approximately 500 patients and their caregivers who participated in the pivotal Phase 3 trials as well as the investigators and health care professionals at more than 30 clinical sites. Our commercial team is vigorously preparing for commercial launch, and we look forward to working with healthcare providers to give patients and caregivers access to YCANTH™ by September 2023.”
Mr. White continued: “Today’s approval of YCANTH™ is a historic transformational moment in medical dermatology, as physicians, patients and caregivers have long sought a safe and effective FDA approved treatment for molluscum. Molluscum, which primarily affects children, is highly contagious and is commonly transmitted in households, schools, swimming pools and other extra-curricular settings. Since molluscum spreads through skin-to-skin contact and the sharing of contaminated objects with its viral lesions, a topical treatment with precise administration is essential towards preventing further transmission. Based on the results from Verrica’s clinical trials, the FDA found that YCANTH™ is safe and effective for patients as young as two years old, providing an important treatment option for patients and caregivers struggling with this disease.”
YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. Local skin reactions included vesiculation, pruritus, pain, discoloration, and erythema.
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. 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 placebo in patients two years of age and older diagnosed with molluscum.
In both trials, a clinically and statistically significant number of patients treated with VP-102 met the primary endpoint of complete clearance of all treatable molluscum lesions. In CAMP-1, 46% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 18% of participants in the vehicle group (p