After a reinspection in February 2022, Verrica Pharmaceuticals received its third Complete Response Letter (CRL) from the FDA for its treatment for molluscum contagiosum, a drug-device combination containing 0.7% cantharidin (VP-102; verrica)1 . The most recent inspection did not cite specific issues with the processing, but Verrica’s contract manufacturing organization (CMO), Sterling Pharmaceutical Services. Sterling manufactures Verrica’s bulk solutions.
The plant was re-inspected approximately 90 days after the FDA deemed the facility a Necessary Voluntary Action (VAI). FDA will not recommend or take regulatory action against Sterling, statement says2which will not affect any current marketing request mentioning the establishment.
Verrica received its first CRL in 2020 when the FDA requested additional details on specific Chemistry, Manufacturing, and Controls (CMS) process components and human factors validation. The FDA regulator did not raise any concerns about clinical shortcomings, but the CRL encouraged discussions about labeling, post-market requirements, and commitments for the drug device.1.
The second CRL issued in 2021 raised concerns about one of the CMO facilities. The production of the cantharidin treatment product was not of concern to the FDA, but rather the overall quality of the CMO site. Verrica said the FDA did not specify any deficiencies in the CMO or that its assessment would affect the application of the treatment.2
“Verrica is extremely disappointed with the Agency’s issuance of the CRL in all of these circumstances. However, as Verrica evaluates all of its options to bring the first FDA-approved treatment for molluscum to market, the one of the greatest unmet needs in dermatology. As soon as possible, he will continue to work collaboratively with the Agency,” said Ted White, President and CEO of Verrica, West Chester, Pennsylvania, in the statement.
The drug-device combination allows for precise topical dosing and targeted delivery of cantharidin. If approved, it could become the first FDA-approved solution to treat molluscum contagiosum, a highly contagious skin disease that affects approximately 6 million people in the United States, mostly children. If Verrica is approved for sale in the United States, VP-102 will be marketed under the “Ycanth” brand.1”
- The FDA hits verrica with a 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/
- Verrica receives a full response letter from the FDA for its NDA for VP-102 as a direct result of deficiencies in the general re-inspection 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/