July 19, 2023 Source: drugdu 128
On July 23, the FDA is set to make a decision on Verrica Pharmaceuticals’ investigational topical treatment VP-102 (cantharidin 0.7% topical solution), which is being proposed to treat molluscum contagiosum.
If approved, VP-102 would become the first authorized treatment for this viral skin infection.
Affecting some six million patients in the U.S. —primarily children—molluscum contagiosum is a highly contagious viral skin disease characterized by distinctive, raised pinkish lesions that are itchy and sometimes painful. In some cases, these bumps can also lead to inflammation and increase the risk of infection.
Molluscum contagiosum is caused by a pox virus that is easily transmissible via fomites or direct skin-to-skin contact. Though usually mild or benign, the disease can persist for several months or years when left untreated.
VP-102 is a drug-device combination containing a 0.7% formulation of cantharidin delivered through a single-use applicator that ensures precise dosing. Verrica has prepared a U.S. brand name of Ycanth if the treatment is approved.
This is Verrica’s third attempt at securing an approval for VP-102. The first was dashed in September 2021, when the FDA rejected its New Drug Application due to deficiencies at a contract manufacturing organization (CMO) facility, according to the company’s news release at the time. These issues were not directly related to VP-102’s manufacturing but pertained to more general quality problems at the plant.
CMO problems also thwarted Verrica’s second filing, which the FDA rejected in May 2022.
Source: bioSpace.com
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