Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. recently announced the US FDA has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Prescription Drug User Fee Act (PDUFA) goal date has been extended by 3 months to September 23, 2021.
The FDA extended the PDUFA goal date to allow the Agency to have additional time to review information submitted by Verrica, including its training program and distribution model, in response to comments from the agency regarding the company’s human factors study. On May 26, 2021, the FDA informed Verrica that the information submitted has been designated a major amendment, which allows FDA to take an additional 3 months to review the submitted information.
“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.”
Verricaʼs lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under US FDA review, with a PDUFA goal date of September 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum ― a common, highly contagious skin disease that affects an estimated 6 million people in the US, primarily children. If approved, VP-102 will be marketed in the US under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.
Molluscum is a highly contagious viral skin disease that affects approximately 6 million people — primarily children — in the US. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching, and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels, or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts, and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.
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