Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has resubmitted the New Drug Application (NDA) for VP-102, aiming to become the first FDA-approved treatment for molluscum contagiosum, affecting over 6 million patients in the U.S., primarily children. This resubmission addresses previous deficiencies highlighted in the Complete Response Letter received last year. VP-102, a topical drug-device combination with 0.7% cantharidin, is designed for precise application. The company also completed Phase 2 studies for treating common and external genital warts. If approved, VP-102 may be marketed as YCANTH™.
- Resubmission of NDA for VP-102 marks a significant advancement towards FDA approval.
- Potential first FDA-approved treatment for molluscum contagiosum, addressing a major unmet medical need.
- VP-102 has completed successful Phase 2 studies for common and external genital warts.
- Previously received Complete Response Letter, indicating regulatory challenges.
Potential First FDA-approved Therapy for Treatment of Molluscum Contagiosum
Prevalence of Over 6 Million Molluscum Contagiosum Patients in the U.S. Alone
WEST CHESTER, Pa., Jan. 24, 2023 (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 resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA).
“We are pleased with the hard work and commitment from the entire Verrica team that has allowed us to resubmit the NDA for VP-102 for molluscum,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals. “We believe the successful tech transfer of our bulk solution manufacturing addresses the only deficiency in our previous filing that resulted in our Complete Response Letter last year. We look forward to working with the FDA through the review process, and if approved, bringing VP-102 to patients as the first FDA-approved treatment option for molluscum.”
About VP-102
Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. 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.
About Verrica Pharmaceuticals Inc.
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 VP- 315 (formerly LTX-315 and VP-LTX-315) for dermatologic oncology conditions. For more information, visit www.verrica.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “look forward,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations with regard to the potential approval of VP-102. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2021 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
Terry Kohler
Chief Financial Officer
tkohler@verrica.com
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
FAQ
What is the significance of Verrica's NDA resubmission for VRCA?
What is molluscum contagiosum and its prevalence in the U.S.?
What are the clinical development milestones achieved by Verrica for VP-102?
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