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Verrica Supports FDA Warning of Unapproved Products to Treat Molluscum Contagiosum

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Article

Verrica’s statement follows the FDA’s warning from June 1, 2023.

Tada Images/AdobeStock
Tada Images/AdobeStock

Following the recent FDA approval of Verrica Pharmaceutical’s VP-102 (Ycanth) in July, Verrica has issued a statement in support of the FDA’s previous warning of the production and sale of unapproved treatments for molluscum contagiosum.1

Verrica’s recent announcement from president and CEO Ted White states, “On the heels of the June 1, 2023, FDA warning to consumers not to use unapproved products for the treatment of molluscum contagiosum, we are pleased the FDA is taking additional measures against these unapproved products. It is clear that the FDA views molluscum as a serious health problem that requires medical intervention with therapies that have been rigorously tested and properly reviewed. Verrica has conducted 2 phase 3 trials to demonstrate the clinical safety and efficacy of Ycanth, so that the millions of people, primarily children, who suffer from this viral infection can finally receive a safe, effective, and FDA-approved treatment for their condition.”1

On June 1, 2023, the FDA issued a warning to health care providers and patients to not use unapproved or nonprescription products to treat molluscum.

In its warning, the FDA said, “Do not purchase or use nonprescription (over-the-counter, or OTC) products that claim to treat molluscum, even if the companies make statements that suggest their product may have been reviewed or is endorsed by the FDA. Some companies may mislead consumers by saying their product is ‘FDA-approved, is FDA registered, is made in an ‘FDA-registered facility,’ or ‘complies with FDA Current Good Manufacturing Practices (or CGMPs). It’s likely that unapproved products marketed to treat molluscum do not do what they claim, and the ingredients in them could cause adverse effects (bad reactions). The FDA has received reports of side effects in children and adults associated with some of these products, including skin reddening, abrasion from skin scratching, and permanent scarring. Many unapproved products claiming to treat molluscum contain essential oils. Even natural substances, such as essential oils, may cause an allergic reaction or irritate sensitive skin.”2

As of July 2023, VP-102 is the only FDA-approved treatment for molluscum contagiosum. The drug-device combination contains a GMP–controlled formulation of cantharidin 0.7% w/v and gentian, a surgical dye meant to clearly mark treated lesions. The precise in-office treatment offers dermatology clinicians and patients a simpler process for treating lesions.

References

1. Verrica issues statement in support of FDA’s warning letters to manufacturers and retailers for producing and selling unapproved products for the treatment of molluscum contagiosum. News release. Verrica Pharmaceuticals. August 23, 2023. Accessed August 23, 2023. https://verrica.com/press_release/verrica-issues-statement-in-support-of-fdas-warning-letters-to-manufacturers-and-retailers-for-producing-and-selling-unapproved-products-for-the-treatment-of-molluscum-contagiosum/

2. Safely treating molluscum, a common skin condition. News release. US Food and Drug Administration. June 1, 2023. Accessed July 23, 2023. https://www.fda.gov/consumers/consumer-updates/safely-treating-molluscum-common-skin-condition

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