Verrica Pharmaceuticals Says FDA Extended Review Period For Its NDA For VP-102

(RTTNews) - Verrica Pharmaceuticals Inc. (VRCA) Friday said the Food and Drug Administration has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum.

The decision date has been extended by the FDA by three months to September 23, 2021.

On May 26, the FDA intimated Verrica that the information submitted by Verrica, including its training program and distribution model, requires additional three months to review.

Verrica had submitted the details after the regulator sought further details including additional Chemistry, Manufacturing and Controls (CMC) information as well as Human Factors validation in its complete response letter issued in July 2020. Verrica had resubmitted the NDA for VP-102 for the treatment of molluscum on December 23, 2020.

Molluscum contagiosum is a viral skin infection characterized by lesions on the skin.

"We remain confident in VP-102 as a potential treatment option for patients with molluscum," said Ted White, Verrica's President and Chief Executive Officer. "Importantly, the FDA has recently completed one of the two pre-approval inspections required for approval. We look forward to our continued productive discussions with the FDA as it completes its review of our VP-102 NDA."