VP-102 Resubmitted to FDA for Molluscum Contagiosum Approval

After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.

VP-102 Resubmitted to FDA for Molluscum Contagiosum Approval

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.

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