Benzinga | Nov 17, 2020 07:32AM EST

Verrica Pharmaceuticals Announces Receipt Of Final FDA Minutes Following Type A Meeting Regarding Resubmission Of NDA For VP-102 In Molluscum; Co. Says Reaffirms Expectation To Resubmit NDA For VP-102 For The Treatment Of Molluscum In Q1 Of 2021

- Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 -

WEST CHESTER, Penn., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company's recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).

VP-102 is a first-in-class, proprietary drug-device combination for the treatment of molluscum, a viral skin disease affecting approximately six million people, primarily children, in the United States. There are currently no FDA-approved treatments for molluscum. In July, the Company announced that it had received a Complete Response Letter from the FDA requesting additional Chemistry, Manufacturing and Controls (CMC) information as well as Human Factors validation.

"We are encouraged by our productive discussion with the FDA and the FDA's written meeting minutes, which reflect alignment on the steps to address the CMC issues raised in the CRL as well as the path forward for resubmission of the NDA and the potential approval of VP-102 to treat patients with molluscum," said Ted White, President and Chief Executive Officer, Verrica. "In addition, our Human Factors study protocol has been reviewed by the FDA and we are preparing to complete that study by the end of the year. We are pleased to reaffirm our expectation to resubmit the NDA for VP-102 pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021."

This news follows Verrica's recent announcement of positive results for VP-102 for the treatment of external genital warts (EGW) in the Phase 2 CARE-1 trial. As previously announced, Verrica intends to request an End-of-Phase 2 meeting with the FDA for VP-102 in EGW in the first quarter of 2021.