Ycanth, a Drug-Device Combo for Molluscum Contagiosum, Gets Approval

The Food and Drug Administration (FDA) has approved Ycanth^™ (cantharidin) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

Ycanth is a drug-device combination product that delivers cantharidin (0.7% w/v), a blistering agent, via a single-use applicator. The approval was based on data from 2 identical randomized, double-blind, multicenter phase 3 trials (ClinicalTrials.gov Identifier: CAMP-1 [NCT03377790] and CAMP-2 [NCT03377803]) that evaluated the efficacy and safety of Ycanth in 528 patients 2 years of age and older with molluscum contagiosum.

Patients were randomly assigned to receive either Ycanth or vehicle applied once to all affected lesions every 21 days for up to 4 applications. Study drug solution was applied and left on the lesions for approximately 24 hours before the lesions were washed with soap and water.

The primary endpoint for both studies was the proportion of patients achieving complete clearance of all treatable molluscum contagiosum lesions by day 84. Secondary endpoints included the proportions of patients achieving complete clearance of all treatable molluscum contagiosum lesions by day 63, day 42, and day 21.

In CAMP-1, the percentage of patients exhibiting complete clearance in the Ycanth arm vs the vehicle arm included the following:

• Day 84: 46% vs 18% (treatment difference, 29%; 95% CI, 19-38);
• Day 63: 32% vs 17% (treatment difference, 15%; 95% CI, 4-25);
• Day 42: 21% vs 9% (treatment difference, 10%; 95% CI, 2-19);
• Day 21: 11% vs 4% (treatment difference, 8%; 95% CI, 2-14).

In CAMP-2, the percentage of patients exhibiting complete clearance in the Ycanth arm vs the vehicle arm included the following:

• Day 84: 54% vs 13% (treatment difference, 40%; 95% CI, 30-51);
• Day 63: 28% vs 5% (treatment difference, 23%; 95% CI, 15-32);
• Day 42: 13% vs 4% (treatment difference, 9%; 95% CI, 3-16);
• Day 21: 5% vs 2% (treatment difference, 3%; 95% CI, -1, 8).

The most common adverse reactions reported with Ycanth were local skin reactions at the application site, including vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion.

Ycanth topical solution is supplied in an ampule contained within a single-use applicator. Each ampule contains approximately 0.45mL of 0.7% cantharidin solution. Health care providers should receive instruction and training prior to preparing and administering Ycanth. The product is expected to be available by September 2023.