The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.
New phase III data on Novan Inc.'s molluscum contagiosum candidate showed it cleared all lesions associated with the highly contagious viral skin infection in 32.4% of trial participants who received it vs. 19.7% provided a placebo. Paired with what company President and CEO Paula Brown Stafford called "strong safety," the result gives the company's team confidence as it moves toward an NDA submission for the topical antiviral, SB-206, she said.
While Novan Inc.’s phase III failure in treating molluscum contagiosum for patients ages 6 months and older battered its stock Friday, the company intends to take the positive data it gleaned to the FDA to discuss an NDA submission and a possible phase III trial for next year.
