FDA approves VP-102 to treat molluscum contagiosum

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Following the resubmission of a new drug application, the FDA has approved VP-102 to treat molluscum contagiosum, a contagious skin disease transmitted through direct skin-to-skin contact that primarily affects children.

FDA approves VP-102 to treat molluscum contagiosum | Image Credit: © Calin - © Calin - stock.adobe.com.

FDA approves VP-102 to treat molluscum contagiosum | Image Credit: © Calin - © Calin - stock.adobe.com.

Verrica Pharmaceuticals’ lead product candidate, VP-102 (YCANTH), has been approved by the FDA to treat molluscum contagiosum in adults and pediatric patients 2 years and up, making it the first FDA-approved product to treat the contagious skin disease, which primarily affects children. 1,2

According to Verrica, VP-102 is a drug-device combination containing a GMP-controlled formulation of cantharidin (0.7% w/v). The product is delivered through a single-use applicator for targeted and controlled dosing. Transmitted through direct skin-to-skin contact, molluscum contagiosum is caused by a virus which creates raised lesions (skin-toned-to-pink colored) which can cause inflammation, pain, itching, and bacterial infection. The disease can also be transmitted through wet surfaces, towels, and other fomites. Molluscum contagiosum, on average, lasts 13 months, but could last multiple years in some cases, according to Verrica.2

In 2 identical, phase 3, randomized, double-blind clinical trials, VP-102 met the primary endpoints of achieving complete clearance of treatable molluscum lesions. The CAMP-1 and CAMP-2 trials (NCT03377790 and NCT03377803) evaluated the safety and efficacy of VP-102 in 528 participants 2 years and older, compared to vehicle. The trials were conducted across 31 US centers.2 Of the 310 participants treated with VP-102, the mean age was 7.5 years (2-60 years). The drug was applied to all baseline and new lesions once every 21 days. Applications were applied until lesions cleared with a maximum of 4 applications. At day 84, 50% of participants that received VP-102 observed complete clearance of all molluscum lesions, compared to 15.6% of vehicle recipients (P < .0001). Mean molluscum lesion counts for VP-102-treated individuals decreased by 76% compared to 0.3% for vehicle-receiving participants at day 84 (P < .0001).3

Previously, Verrica Pharmaceuticals resubmitted a new drug application (NDA) with the FDA for potential approval of VP-102, which is also being developed to treat common warts and external genital warts, some of the largest unmet needs in medical dermatology.4

References:

  1. Breaking news: Verrica announced the approval of YCANTH (cantharidin) topical solution 0.7%. Verrica Pharmaceuticals. Press release. July 21, 2023. Accessed July 22, 2023. https://verrica.com/our-medicines/ycanth/
  2. Pipeline VP-102 - Verrica Pharmaceuticals. Accessed July 21, 2023. https://verrica.com/pipeline-vp-102/
  3. Eichenfield LF, Siegfried E, Kwong P, et al. Pooled results of two randomized phase III trials evaluating VP-102, a drug-device combination product containing cantharidin 0. 7%(W/v) for the treatment of molluscum contagiosum. Am J Clin Dermatol. 2021;22(2):257-265. doi:10.1007/s40257-020-00570-8
  4. Krewson C. FDA accepts application for VP-102 for treating molluscum contagiosum. Contemporary Pediatrics. March 1, 2023. Accessed July 21, 2023. https://www.contemporarypediatrics.com/view/fda-accepts-application-for-vp-102-for-treating-molluscum-contagiosum
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