FDA Issues Second CRL for Poxvirus Treatment

Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.

The FDA has issued a complete response letter (CRL) for Verrica Pharmaceuticals’ new drug application (NDA) for VP-102 for the treatment of molluscum contagiosum, an infection caused by poxvirus. This infection is usually a mild skin disease characterized by lesions that may appear anywhere on the body, according to the CDC. But there is currently no approved treatments for this infection, which affects about 6 million people worldwide, mostly children.

VP-102 is a proprietary drug-device combination product that contains a formulation of cantharidin delivered via a single-use applicator that allows for topical dosing and targeted administration. If approved, it would be the first product approved to treat molluscum contagiosum.

The FDA indicated in the CRL that there were deficiencies identified at a general reinspection of Sterling Pharmaceuticals, the contract manufacturing organization that manufactures Verrica’s bulk solution drug product.

Sterling advised Verrica on May 20, 2022, that it received notice from the called Official Action Indicated (OAI). This was the result of a week-long reinspection of Sterling conducted by FDA in February 2022. The reinspection was conducted about 90 days after Sterling was originally classified by the agency as Voluntary Action Indicated (VAI) on November 17, 2021.

Verrica indicated in a press release no other deficiencies indicated and that the deficiencies weren’t specific to VP-102.

FDA’s policy prevents it from approving the NDA when a contract manufacturing organization has an unresolved classification status or is placed on OAI status.

“Our understanding is that the division was ready to communicate our label, and we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy, or safety of VP-102,” Ted White, Verrica’s president and chief executive officer, said in a press release. “However, we recognize that the dermatology division’s hands may be tied due to the reinspection issues at Sterling and thank them for their efforts working with us to date.”

This is the second CRL issued for VP-102. The first was in September 2021 because of the VAI status of Sterling’s manufacturing plant.

The NDA submission was based on positive results from two identical phase 3 clinical trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102 compared with placebo in a combined 500 subjects two years of age and older diagnosed with molluscum. In both trials, a clinically and statistically significant number of patients treated with VP-102 met the primary endpoint of complete clearance of all treatable molluscum lesions at the end of the trial. VP-102 was well-tolerated in both trials, with no serious adverse events reported and a dropout rate of less than 2%.