FDA Issues Third CRL in 2 years to Verrica Pharmaceuticals

Verrica is complying with the FDA through 3 Complete Response Letters to achieve the first FDA-approved treatment of molluscum contagiosum.

After a February 2022 re-inspection, Verrica Pharmaceuticals received its third Complete Response Letter (CRL) from the FDA for their molluscum contagiosum treatment, drug–device combination containing cantharidin 0.7% (VP-102; Verrica)1 . The most recent inspection did not cite specific issues with the treatment, but Verrica’s contract manufacturing organization (CMO), Sterling Pharmaceutical Services. Sterling manufactures Verrica’s bulk solution products.

The plant was re-inspected about 90 days after the FDA deemed the facility as Voluntary Action Needed (VAI). The FDA will not recommend or take regulatory action against Sterling, according to the release2, which will not affect any pending marketing application which mentions the facility.

Verrica received its first CRL in 2020 when the FDA requested additional details about specific components of the chemistry, manufacturing and control (CMS) processes, and Human Factors validation. The FDA regulator did not raise any concerns regarding clinical deficiencies, but the CRL encouraged discussions about labeling, post-marketing requirements, and commitments for the drug-device1.

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.2

"Verrica is extremely disappointed in the Agency's issuance of the CRL under the totality of these circumstances. 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," said Ted White, president and CEO of Verrica, West Chester, Pennsylvania, in the release.

The drug-device combination allows accurate topical dosing and targeted administration of cantharidin. If approved, it could become the first FDA-approved solution to treat molluscum contagiosum, a highly contagious skin disease that affects around 6 million people in the United States, primarily children. If Verrica receives permission to sell in the United States, VP-102 will be marketed under the brand name “Ycanth.1

References:

  1. FDA hits verrica with third CRL for lead drug candidate VP-102. BioSpace. Accessed June 15, 2022. https://www.biospace.com/article/verrica-receives-third-crl-for-molluscum-contagiosum-drug-device-candidate/
  2. 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. Accessed June 29, 2022. 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/