Torii Pharmaceutical Submits NDA in Japan for Verrica's Molluscum Contagiosum Treatment, TO-208
Key Insights
Torii Pharmaceutical (search) has submitted a New Drug Application (NDA) in Japan for TO-208, a cantharidin-based treatment for molluscum contagiosum (search).
TO-208, known as YCANTH® in the U.S., could be the first approved molluscum treatment in Japan, addressing a significant unmet need affecting 1.6 million people.
Phase 3 trials in Japan demonstrated TO-208's superiority over the vehicle, with a safety profile consistent with U.S. studies, supporting the NDA submission.
Torii Pharmaceutical (search) Co. Ltd., Verrica Pharmaceuticals' partner, has submitted a New Drug Application (NDA) in Japan for TO-208, a cantharidin-based treatment for molluscum contagiosum (search). This submission marks a significant step toward potentially providing the first approved therapy for this highly contagious skin condition in Japan, where an estimated 1.6 million people, primarily children, are affected.
Promising Clinical Trial Results
Clinical trials for TO-208 in Japan have yielded promising results. The Phase 3 study successfully met its primary endpoint, demonstrating the drug’s efficacy compared to a vehicle treatment. The safety profile of TO-208 in the study was consistent with previous trials conducted in the U.S., with no significant tolerability issues reported.
Addressing an Unmet Need
Molluscum contagiosum (search) is a common skin disease caused by a poxvirus. It is characterized by raised, pearly nodules on the skin. The condition is highly contagious, particularly among children. Currently, there are no approved treatments for molluscum contagiosum in Japan, making TO-208 a potentially valuable therapeutic option.
Jayson Rieger, Ph.D., MBA, President and CEO of Verrica Pharmaceuticals, emphasized the importance of this milestone, stating, “Torii continues to be an outstanding partner in advancing TO-208 for the treatment of molluscum, and today’s NDA submission represents the next critical milestone towards bringing to market the first therapeutic for addressing this indication in Japan.”
Strategic Partnership
The NDA submission is the result of an exclusive license agreement between Verrica and Torii, signed in March 2021, granting Torii the rights to develop and commercialize TO-208 for molluscum and common warts (search) in Japan. Verrica has already secured U.S. FDA approval for YCANTH® (VP-102), a similar cantharidin-based product, for treating molluscum contagiosum (search) in patients aged two years and older. YCANTH® was launched in the U.S. in August 2023.
About YCANTH®
YCANTH® is a proprietary drug-device combination containing a precisely dosed formulation of cantharidin for topical application by healthcare professionals. Its approval in the U.S. was based on two successful Phase 3 clinical trials involving approximately 500 patients, establishing it as a safe and effective treatment. YCANTH® should only be administered by a trained healthcare professional and is not for home use.
With this NDA submission, Torii and Verrica aim to expand the availability of TO-208 globally, addressing a significant gap in treatment for millions affected by molluscum contagiosum (search).