The Food and Drug Administration (FDA) has accepted for filing the New Drug Application for cantharidin 0.7% topical solution (VP-102; Verrica Pharmaceuticals) for the treatment of molluscum contagiosum, a viral skin infection.
Cantharidin is a blistering agent that has been used since the 1950s to treat molluscum contagiosum and warts. It was removed from the market in 1962 after the FDA required manufacturers to submit efficacy data for their products.
The NDA for Verrica’s investigational therapy includes data from two phase 3 double-blind, placebo-controlled clinical trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of cantharidin 0.7% topical solution in patients ≥2 years old diagnosed with molluscum contagiosum. Results from both trials showed a clinically and statistically significant number of patients treated with topical cantharidin exhibited complete clearance of all treatable molluscum lesions (primary end point). The treatment was also found to be well-tolerated with no serious adverse events reported.
Currently, there are no FDA-approved treatments for molluscum contagiosum. As the condition is self-limited in otherwise healthy patients, it is often left untreated. Physical removal of lesions, oral therapy (ie, cimetidine), and other topical agents have been used as treatments but with mixed results. “Left untreated, molluscum is easily transmitted, with lesions persisting an average of 13 months, and molluscum can last up to several years, as seen in our clinical trials,” said Ted White, President and Chief Executive Officer, Verrica. “The acceptance of this NDA for review is the next step toward bringing patients and their caregivers a safe and effective topical therapy for this common, highly contagious viral skin disease that carries a substantial social stigma.”
A Prescription Drug User Fee Act (PDUFA) target date of July 13, 2020 has been assigned to the application.
For more information visit verrica.com.