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Verrica Flat on Forwarding NDA to FDA Verrica Pharmaceuticals Inc. (NASDAQ: VRCA) shares made only slight gians Tuesday on word 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).
Verrica's 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 could potentially be the first product approved by the FDA to treat molluscum contagiosum - a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children.
Upon resubmission of the NDA for VP-102, Verrica intends to seek conditional approval to market VP-102 in the United States under the brand name YCANTHTM. 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.
“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 CEO Ted White.“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.”
VRCA shares advanced seven cents, or 1.5% to $4.68.
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