In a recent announcement, Verrica Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved cantharidin (YCANTH™) for the treatment of molluscum contagiosum in pediatric and adult patients.
Cantharidin is a topical solution for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients aged two years and older. It is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator which allows for precise topical dosing and targeted administration by a health care professional.
The FDA’s approval of cantharidin comes after two identical Phase 3 randomized, double-blind trials, CAMP-1 and CAMP-2, evaluated the safety and efficacy of VP-102 (YCANTH™) compared to placebo.
Both CAMP-1 and CAMP-2 trials met the primary endpoint of complete clearance of all treatable molluscum lesions. In the CAMP-1 trial, 46% of all patients treated with VP-102 achieved complete clearance compared to 18% in the vehicle group. For the CAMP-2 trial, 54% of those treated with VP-102 achieved complete clearance compared to only 13% of those who received placebo.
Furthermore, post-hoc analysis also revealed that the percentage of participants with complete molluscum clearance at the end of the trial was significantly higher across all age groups for those treated with VP-102 than those treated with vehicle.
Researchers noted no serious adverse reactions. Most adverse reactions were mild to moderate.
“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. 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.”
Verrica plans to make cantharidin available by September 2023.
