Ycanth is a drug-device combination that contains a formulation of cantharidin (0.7%w/v) delivered through a single-use applicator, for precise topical dosing and targeted administration, administered by a healthcare professional, to treat molluscum
Ycanth is indicated for the treatment of Molluscum. (Credit: Mediamodifier from Pixabay)
US-based dermatology therapeutics company Verrica Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Ycanth (cantharidin) topical solution to treat molluscum contagiosum in adults and children, aged two years and above.
Ycanth is a unique drug-device combination, containing a formulation of cantharidin (0.7%w/v) delivered through a single-use applicator, for precise topical dosing and targeted administration.
The drug is intended for topical use only and is warned against oral, mucosal, or ophthalmic use as it may cause fatal toxicities and may cause skin reactions at the application site.
In the clinical trials, around 97% of subjects treated with Ycanth had local skin reactions at the application site, including vesiculation, pruritus, pain, discolouration, and erythema.
Verrica intends to commercialise Ycanth available by September 2023.
Verrica president and CEO Ted White said: “We are proud to bring patients and caregivers the first FDA-approved treatment for molluscum, which is one of the largest unmet needs in medical dermatology.
“Verrica is the first company to develop a proprietary applicator and GMP formulation of cantharidin that allows a safe, effective and precise topical administration, and the first company to successfully gain FDA approval after conducting rigorous clinical trials to evaluate the safe and effective use of a cantharidin-based product for the treatment of molluscum.
“Our commercial team is vigorously preparing for commercial launch, and we look forward to working with healthcare providers to give patients and caregivers access to Ycanth by September 2023.”
The FDA approval is based on positive results from two identical Phase 3 randomised, double-blind, multicentre clinical trials, CAMP-1 and CAMP-2.
The two studies evaluated the safety and efficacy of Ycanth, compared to placebo in patients two years of age and older diagnosed with molluscum.
In the two studies, a significant number of patients treated with Ycanth achieved complete clearance of all treatable molluscum lesions, which is the primary endpoint.
Around 46% of participants in the CAMP-1, achieved complete clearance of molluscum lesions compared to 18% of participants in the vehicle group.
In the CAMP-2 study, 54% of participants treated with Ycanth achieved complete clearance of molluscum lesions compared to 13% of participants in the vehicle group.
Ted White added: “Today’s approval of Ycanth is a historic transformational moment in medical dermatology, as physicians, patients and caregivers have long sought a safe and effective FDA-approved treatment for molluscum.
“Molluscum, which primarily affects children, is highly contagious and is commonly transmitted in households, schools, swimming pools and other extra-curricular settings.
“Since molluscum spreads through skin-to-skin contact and the sharing of contaminated objects with its viral lesions, topical treatment with precise administration is essential towards preventing further transmission.
“Based on the results from Verrica’s clinical trials, the FDA found that Ycanth is safe and effective for patients as young as two years old, providing an important treatment option for patients and caregivers struggling with this disease.”
Molluscum is a highly contagious viral skin disease, caused by a pox virus, that produces distinctive raised lesions that can cause pain, inflammation, itching and bacterial infection.