VP-102 could be the first approved drug on the market in the US to treat molluscum contagiosum.
Dermatology therapeutics company Verrica Pharmaceuticals Inc. (“Verrica”) announced the successful completion of the technology transfer of bulk solution manufacturing to Piramal Pharma Solutions.1 According to a company press release, the technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of 3 process validation batches of bulk solution.
Verrica President and Chief Executive Officer Ted White said he believes the tech transfer will be well-received by the US Food and Drug Administration (FDA) and completes a substantial requirement toward the resubmission of their NDA for VP-102 for the treatment of molluscum in the first quarter of 2023.
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. Verrica has successfully completed a phase 2 study of VP-102 for the treatment of common warts and a phase 2 study for the treatment of external genital warts. Verrica intends to seek conditional approval to market VP-102 under the brand name YCANTH™.
If approved by the FDA, it will be the first product to treat molluscum contagiosum. The common, highly contagious skin disease affects an estimated 6 million people in the US. Most patients are children. Molluscum is caused by a pox virus that produces raised, pink-colored lesions that can cause pain, inflammation, itching and bacterial infections. Without treatment, it can last an average of 13 months to several years.
1. Verrica Pharmaceuticals Announces the Successful Technology Transfer of Bulk Solution Manufacturing of VP-102 to Piramal Pharma Solutions. https://wwwglobenewswirecom/news-release/2023/01/04/2582803/0/en/Verrica-Pharmaceuticals-Announces-the-Successful-Technology-Transfer-of-Bulk-Solution-Manufacturing-of-VP-102-to-Piramal-Pharma-Solutionshtml. January 4, 2023. https://verrica.com/. Accessed January 6, 2023.