The FDA accepted Verrica Pharmaceuticals’ (NASDAQ:VRCA) NDA for its molluscum contagiosum drug candidate, VP-102, assigning a PDUFA date of July 13, 2020.
VP-102 is a topical cantharidin solution designed to treat molluscum contagiosum, a viral skin infection.
Verrica’s NDA is based on positive results from two Phase 3 trials, both of which demonstrated VP-102’s superior efficacy in clearing all treatable lesions, compared with placebo.
“There are no FDA-approved treatments currently available to patients diagnosed with molluscum, the majority of whom are children, leaving caregivers to choose between a wait-and-see approach or treatments with unproven efficacy,” president and CEO Ted White said in a statement.
“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,” he added.