Verrica Pharmaceuticals' Resubmitted NDA for VP-102 Accepted by FDA

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Verrica Pharmaceuticals announced that the US Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7%) for the treatment of molluscum contagiosum after 3 Complete Response Letters (CRL). The FDA has given Verrica Pharmaceuticals a Prescription Drug User Fee Act (PDUFA) date of July 23, 2023.¹

Verrica Pharmaceuticals received its most recent CRL from the FDA for VP-102 after a February 2022 re-inspection. The February inspection did not cite specific issues with the drug, but Verrica’s contract manufacturing organization (CMO), Sterling Pharmaceutical Services, which manufactures Verrica’s bulk solution products. The plant was re-inspected 90 days after the FDA deemed the facility as Voluntary Action Needed.²

Verrica received its first CRL in 2020 when the FDA requested additional details about specific components of the chemistry, manufacturing and control processes, and Human Factors validation. The FDA regulator did not voice concerns about clinical deficiencies, but the CRL encouraged discussions about labeling, post-marketing requirements, and commitments for the drug-device.²

The second CRL issued in 2021 raised concerns about one of the CMO’s facilities. Product production of the cantharidin treatment did not concern the FDA, but instead the overall quality of the CMO location. Verrica stated that the FDA did not specify any deficiencies at the CMO or that its evaluation would affect the treatment's application.³

Ted White, Verrica’s president and chief executive officer noted Verrica is glad that the FDA has accepted their new NDA submission for VP-102 and hopes to see their drug provide the first FDA-approved treatment option for molluscum contagiosum. White explained that VP-102 is designed for targeted administration of cantharidin through a topical GMP-controlled formulation through a single-use applicator.

There are currently no FDA-approved treatment options for molluscum contagiosum, which affects primarily pediatric patients in the United States.

References

1. Verrica Pharmaceuticals announces FDA acceptance of filing of resubmitted NDA for VP-102 for the treatment of molluscum contagiosum. Verrica Pharmaceuticals. Published February 27, 2023. Accessed February 28, 2023. https://verrica.com/press_release/fda-accepts-resubmitted-filing-for-vp-102-for-the-treatment-of-molluscum-contagiosum/
2. FDA hits Verrica with third CRL for lead drug candidate VP-102. BioSpace. Published May 25, 2022. Accessed February 28, 2023. https://www.biospace.com/article/verrica-receives-third-crl-for-molluscum-contagiosum-drug-device-candidate/
3. Verrica receives complete response letter from the FDA for its NDA for VP-102 as a direct result of deficiencies at general reinspection of Sterling Pharmaceuticals Services, LLC - Verrica Pharmaceuticals. Published May 24, 2022. Accessed February 28, 2023. https://verrica.com/press_release/verrica-receives-complete-response-letter-from-the-fda-for-its-nda-for-vp-102-as-a-direct-result-of-deficiencies-at-general-reinspection-of-sterling-pharmaceuticals-services-llc/