FDA Cites Manufacturing Deficiencies in Second Complete Response Letter for Verrica’s VP-102


Verrica received a Complete Response Letter from the FDA regarding their New Drug Application for the topical molluscum contagiosum treatment, VP-102.

Verrica’s received a Complete Response Letter from the FDA regarding their New Drug Application for the topical molluscum contagiosum treatment, VP-102. This is Verrica’s second CRL, and both resulted from deficiencies identified at Verrica’s manufacturer, Sterling Pharmaceuticals Services.

Yesterday, Verrica Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for VP-102, their molluscum contagiosum treatment.

This is Verrica’s second time filing a New Drug Application (NDA) for VP-102, and their second time receiving a CRL in response to manufacturing concerns.

In the CRL, the FDA cited deficiencies identified at Sterling Pharmaceuticals Services, LLC (Sterling), the contract manufacturing organization that produces VP-102. A pre-approval inspection (PAI) had been conducted at Sterling. Verrica said their NDA review was completed and they were set to be notified of their label, had it not been for Sterling’s Official Action Indicated (OAI) status.

“Based on the successful PAI of VP-102 at Sterling and our understanding that the Division was ready to communicate our label, 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,” said Ted White, Verrica’s president and CEO.

Verrica had aspired for VP-102 to become the first FDA-authorized treatment for the common and highly contagious skin disease molluscum contagiosum (molluscum). Verrica shared their CRL yesterday, May 25, on what had been their Prescription Drug User Fee Act (PDUFA) target action date.

Molluscum affects approximately 6 million people in the US alone, most of whom are children. Verrica remains hopeful that they can address the manufacturing concerns and “We look forward to potentially bringing treatment and relief to thousands of patients, primarily children, suffering from molluscum, starting with a sales focus in Dermatology, Pediatric Dermatology and key academic centers and health systems,” said Ted White, Verrica president and CEO.

Verrica had originally received a Complete Response Letter (CRL) from the FDA on September 16, 2021. The CRL noted the FDA formally delayed consideration of VP-102 due to deficiencies at a Sterling manufacturing facility. The quality issues were not directly connected to VP-102, but the agency wanted additional time to review requested information from Verrica.

“More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls deficiencies related to VP-102,” Verrica said at the time they received notice of the initial delay.

The FDA classified Sterling as Voluntary Action Indicated (VAI) after a facility reinspection on November 17, 2021, leading Verrica to believe no further action or reinspection was required. Thus, Verrica resubmitted an NDA for VP-102 on November 24, 2021.

The resubmission came after positive results from the identical phase 3 randomized, double-blind, multicenter clinical trials, CAMP-1 and CAMP-2. The trials evaluated the safety and efficacy of VP-102 versus placebo in persons diagnosed with molluscum. Of the 500 participants, aged 2 years and older, a clinically and statistically significant number met the primary endpoint of complete clearance of treatable molluscum lesions.

VP-102 was well-tolerated in both trials, treating nearly 8000 lesions with bulk solution manufactured at Sterling. There were no serious adverse events reported, and the dropout rate was under 2%.

VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidin (0.7% w/v). Its single-use applicator enables precise, targeted administration of the topical treatment. If approved, VP-102 would be marketed under the brand name Ycanth.

Molluscum is caused by a pox virus that produces sin-toned-to-pink-colored raised lesions. These bumps can cause pain, inflammation, itching, and bacterial infection. Molluscum is easily transmitted, through both skin-to-skin contact or via objects and surfaces. Without treatment, the infection lasts for an average of 13 months, and in some cases can linger for several years.

In addition to treating molluscum, VP-102 has demonstrated ability to treat common warts and external genital warts in phase 2 studies. Verrica is also developing its second cantharidin-based product, VP-103, to treat plantar warts.

Verrica is reportedly working with Sterling to present multiple options to satisfy the deficiencies to the FDA. At the same time, Verrica is recruiting an additional contract manufacturing organization to serve as an alternative supplier of VP-102.

“Verrica is extremely disappointed in the Agency’s issuance of the CRL under the totality of these circumstances,” White said. “However, as Verrica weighs all its options to bring the first FDA-approved treatment for molluscum, one of the largest unmet needs in dermatology, to the market as soon as possible, it will continue to work collaboratively with the Agency.” Verrica is planning to file a Type A meeting request by the end of this week.

Recent Videos
© 2024 MJH Life Sciences

All rights reserved.