After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.
Verrica Pharmaceuticals has resubmitted the New Drug Application (NDA) for investigative topical therapy VP-102 for the treatment of molluscum contagiosum.
The latest submission to the US Food and Drug Administration (FDA) comes after the company received a Complete Response Letter (CRL) for its NDA in 2021, at which time the agency identified issues with a contract manufacturing organization (CMO) facility relevant to the drug. However, Verrica denied the facility in question was specifically related to the manufacturing of VP-102. They additionally noted the FDA had not identified deficiencies related to the product’s clinical, safety, chemistry, manufacturing or control characteristics in the CRL.
With the announced NDA resubmission, Verrica highlighted a “successful tech transfer” of bulk solution manufacturing to resolve the CRL issue. “We look forward to working with the FDA through the review process, and if approved, bringing VP-102 to patients as the first FDA-approved treatment option for molluscum,” Verrica president and chief executive officer Ted White said in a statement.
VP-102 is a drug-device combination therapy featuring a single-use, topical, targeted application of 0.7% w/v cantharidin to treat molluscum. Pooled analysis of a pair of phase 3 trials assessing the agent in pediatric and adult patients with molluscum showed mean lesion counts in treated patients decreased by 76%, versus just 0.3% in patients treated with vehicle at day 84 (P <.0001). Approximately half of all patients to receive VP-102 achieved complete molluscum lesion clearance at day 84 (P <.0001).
Common adverse events associated with VP-102 were mild-to-moderate application site blistering, pruritus, pain and erythema.
Molluscum is a highly contagious viral skin infection caused by pox virus that results in painful, inflammatory and irritated lesions. Untreated cases can last for a mean 13 months, or up to several years. A majority of the approximate 6 million patients in the US are children, and no treatment is currently approved by the FDA.
VP-102 is additionally being assessed for the treatment of common warts and external genital warts, with Verrica having recently completed phase 2 clinical trials for both patient populations.