FDA Approves Verrica Pharma's Ycanth: First Treatment Of Molluscum Contagiosum Impacting 6M People In US

The FDA approved Verrica Pharmaceuticals Inc's VRCA Ycanth (cantharidin) topical solution for molluscum contagiosum (molluscum) in adult and pediatric patients two years of age and older.

Molluscum contagiosum is an infection caused by a poxvirus. The result of the infection is usually a benign, mild skin disease characterized by lesions (growths) that may appear anywhere on the body. 

Within 6-12 months, Molluscum contagiosum typically resolves without scarring but may take as long as four years.

Ycanth, a proprietary drug-device combination product, is for topical use only.

It contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator, allowing for precise topical dosing and targeted administration. 

Citing Needham, Reuters noted estimated the price would be around $500 an applicator and estimates peak sales in the range of $200 million.

Verrica plans to make Ycanth available by September 2023.  

The approval is based on results from two identical Phase 3 trials (CAMP-1 and CAMP-2).

In both trials, a clinically and statistically significant number of patients treated with VP-102 met the primary endpoint of complete clearance of all treatable molluscum lesions. 

In CAMP-1, 46% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 18% of participants in the vehicle group.

In CAMP-2, 54% of participants treated with VP-102 achieved complete clearance of molluscum lesions compared to 13% of participants in the vehicle group.

Additional post-hoc analyses of the CAMP trials showed that complete clearance of all lesions was statistically significantly higher in the VP-102 group than vehicle across all body regions.

Price Action: VRCA shares are down 20.60% at $5.92 during the premarket session on the last check Monday.