A new drug application for VP-102 for treating molluscum contagiosum has been accepted by the FDA.
The FDA has accepted a resubmitted new drug application (NDA) for VP-102 (YCANTH; Verrica Pharmaceuticals) for treating molluscum contagiosum, a skin disease commonly seen in young people.
About 6 million people in the United States experience molluscum contagiosum, with most cases being seen in children. The skin disease is highly contagious, leading to pain-causing lesions which can be skin-toned to pink-toned. These lesions also cause inflammation, itching, and bacterial infection.
Transmission of molluscum contagiosum is highly likely through fomites and direct skin-to-skin contact. The average case can last up to 13 months without treatment, with some lasting for multiple years. Currently, there are no FDA-approved treatments for molluscum.
VP-102 delivers cantharidin through a single-use applicator, leading to accurate dosing and targeted administration. The proprietary drug-device combination product could be the first approved by the FDA for treating molluscum contagiosum. Currently, it has completed a phase 2 study for treating common warts and a phase 2 study for treating external genital warts.
According to Ted White, president and chief executive officer of VerricaPharmaceuticals, VP-102 has shown strong safety and efficacy results for treating molluscum contagiosumin 2 phase 3 trials. July 23, 2023 is the Prescription Drug User Fee Act date currently set for the product.
"I am excited about the possibility of the Verrrica-102 cantharidin treatment for molluscum receiving approval," said Bernard Cohen, MD, professor of pediatrics and dermatology at Johns Hopkins University School of Medicine. "The company is 1 step closer, and we all await further consideration by the FDA."
Verrica Pharmaceuticals is a therapeutics company focused on dermatology. Medications developed by the company are for skin diseases which need medical interventions, with VP-102 being developed for 3 of the largest unmet needs in medical dermatology: common warts, external genital warts, and molluscum contagiosum.
Verrica Pharmaceuticals announces FDA acceptance of filing of resubmitted NDA for VP-102 for the treatment of molluscum contagiosum.BioSpace. February 27, 2023. Accessed February 28, 2023. https://www.biospace.com/article/releases/verrica-pharmaceuticals-announces-fda-acceptance-of-filing-of-resubmitted-nda-for-vp-102-for-the-treatment-of-molluscum-contagiosum/