YCANTH

Pharmacokinetics of cantharidin were assessed in 16 subjects aged 2 years and older with at least 21 molluscum contagiosum lesions at baseline. Subjects were administered a single, dermal application of cantharidin solution to each lesion. The average number of lesions treated for subjects in the exposure treatment group was 47.4 (median was 35.0). Cantharidin was not detectable in 15 out of 16 subjects. Only one subject had a detectable cantharidin plasma level of 3.391 ng/mL at the 2-hour post...

In two double-blind, randomized, placebo-controlled trials (Trial 1 [NCT03377790] and Trial 2 [NCT03377803]), 528 subjects ages 2 years and older with molluscum contagiosum were randomized by household to treatment with either YCANTH or vehicle. Subjects ranged from 2 to 60 years of age, with a median age of 6. 51% of subjects were male and 91% were Caucasian. The baseline lesion count among subjects ranged from 1 to 184, with a mean of 23 and 19 lesions among subjects in Trial 1 and Trial 2, respectively. Subjects' lesions were treated with either YCANTH or vehicle at intervals of approximate...

The following adverse reactions are described elsewhere in the labeling: Local Skin Reactions [see Warnings and Precautions (5.2) ] Most common (incidence ≥1%) adverse reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-837-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwa...

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Toxicities Associated with Inappropriate Administration: Life threatening or fatal toxicities can occur if administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes. ( 5.1 ) Local Skin Reactions : Reactions at the application site have included vesiculation, pruritus, pain, discoloration, and erythema. Avoid application n...