FDA approves first treatment for molluscum contagiosum

Action

FDA has approved Ycanth (cantharidin) for the topical (used on the skin) treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. Ycanth is the first FDA-approved treatment for molluscum. Ycanth is administered to patients only by health care providers. Providers apply a single application of Ycanth on the areas of patients’ skin with molluscum bumps every 3 weeks as needed.

Disease or Condition

Molluscum contagiosum is a viral skin infection that can cause white, pink, or flesh-colored bumps that may itch or become irritated. These bumps can happen alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, stomach, and genital area. Molluscum is transmitted by skin-to-skin contact and can affect anyone at any age, though it’s most common among children under 10.

Efficacy

The efficacy of Ycanth for the treatment of molluscum in patients 2 years and older was established in two double-blind, randomized, placebo-controlled trials (Trial 1 [NCT03377790] and Trial 2 [NCT03377803]). In the trials, 528 subjects ranging from ages 2 to 60 years with molluscum contagiosum were randomized by household to receive either Ycanth or a placebo treatment.

Subjects received treatment or placebo at 21-day intervals until bumps were completely cleared or for a maximum of four applications. A health care professional who was blinded to the treatment group counted the number of lesions at each visit. The primary efficacy endpoint was the proportion of subjects achieving complete clearance of all treated molluscum bumps by day 84.

Fifty-four percent of subjects treated with Ycanth achieved complete clearance of all treated molluscum bumps by day 84 compared to 13% of subjects treated with placebo.

Safety

The most common adverse reactions to Ycanth occurred at the application site, and included blistering, pain, itching, scabbing, reddening, discoloration, dryness, edema (swelling), and erosion of the skin. Life threatening or fatal toxicities can occur if administered orally. Contact with the treatment area should be avoided, including oral contact, after treatment. Ycanth is flammable, even after drying. Patients should avoid fire, flame, or smoking near lesion(s) during treatment and after application until removed. See full prescribing information for additional information on risks associated with Ycanth.

Designations

Ycanth received standard review for this indication.