The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for the company’s NDA is July 13, 2020.
Verrica Pharmaceuticals (NASDAQ:VRCA) has announced that the US Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) for its VP-102 to treat molluscum contagiosum.
As quoted in the press release:
The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is July 13, 2020.
“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,” said Ted White, President and Chief Executive Officer, Verrica. “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. 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. We look forward to working closely with the FDA during this review period.”
The NDA 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 compared to placebo in patients two years of age and older diagnosed with molluscum. CAMP-1 was conducted under a SPA (Special Protocol Assessment) with the FDA. 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.