Verrica Pharmaceuticals Holds Type A Meeting With FDA for VP-102 for Molluscum Contagiosum

Verrica Pharmaceuticals Inc. recently announced the company held a Type A meeting with the US FDA on June 27, 2022, regarding the path forward for the resubmission and potential approval of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).

“We are pleased with our communications with the FDA leading up to and during yesterday’s Type A meeting,” said Ted White, Verrica’s President and Chief Executive Officer. “In particular, we are encouraged by the FDA’s willingness to work collaboratively with us on the amount of stability data required from an alternative contract manufacturing organization (CMO) for our bulk solution at the time of resubmission as well as our options for post-approval use of bulk solution previously manufactured. We remain confident in VP-102 as the potential first FDA-approved treatment option for molluscum, and we continue to be encouraged by the overwhelming support from caregivers and the medical community.”

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 6 million people in the US, primarily children. If approved, VP-102 will be marketed in the United States 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.

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 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.