There were two molluscum new drug applications (NDA) approved by the U.S. Food and Drug Administration (FDA). Verrica Pharmaceuticals announced that the FDA accepted for filing the company's resubmitted NDA for VP-102 for the treatment of molluscum contagiosum and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 23, 2023. Novan announced FDA approval for its berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum. The company also received its PDUFA goal date of January 5, 2024.
VP-102 is a 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 is seeking conditional approval to market VP-102 in the U.S. under the 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.
“We are pleased that the FDA has accepted for filing our NDA resubmission for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “With no FDA-approved treatments for molluscum, the filing acceptance of our NDA brings us one step closer towards providing a safe and effective therapeutic treatment option for the millions of patients in the United States with molluscum."
Novan’s berdazimer gel, 10.3% (SB206) is a topical prescription gel for the treatment of molluscum contagiosum. The company also has a pipeline of potential product candidates using its nitric oxide-based technology platform, NITRICIL, to generate new treatments for multiple indications.
“The opportunity for our NDA to be approved in less than 10 months from today marks a significant and important milestone for Novan and its shareholders. We believe our NCE can provide a much-needed therapeutic option for molluscum patients with the added benefit of being an easily applied, topical, self-administered treatment,” said Paula Brown Stafford, President and Chief Executive Officer of Novan.