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Verrica Pharmaceuticals has has received his third Complete Response Letter (CRL) from the United States Food and drug administration for its New Drug Application for its candidate VP-102 for the treatment of molluscum contagiosum.
The first CRL was Posted in July 2020, with the FDA seeking additional details on certain aspects of the Chemistry, Manufacturing, and Control (CMC) and Human Factors Validation process. The regulator did not identify any clinical deficiencies at the time, but the issues raised affected discussions about labeling and post-marketing requirements and commitments for the drug-device.
While Verrica complied with what was asked of her and resubmitted her NDA, VP-102 was once again issued a CRL in September 2021. This time, the FDA identified certain concerns at a contract manufacturing organization (CMO) facility that, while not directly related to the production of VP-102, raised general quality issues regarding the location.
Verrica said the regulator did not advise them of any shortcomings at the CMO or that its assessment of the facility would affect VP-102’s candidacy. The FDA also reportedly did not mention any clinical, safety, or product-specific CMC issues in its CRL.
In the third and most recent letter, following a re-inspection conducted in February 2022, Verrica noted that none of the issues were specific to VP-102 and its manufacture. The third CRL only listed issues from the CMO of the company, Sterling Pharmaceuticals Services, which manufactures Verrica’s bulk solution product.
The re-inspection was conducted approximately 90 days after the FDA classified the facility as Voluntary Action Indicated (VAI). Further, under the VAI, it was understood that the FDA would not recommend or take regulatory action against Sterling. This would not affect any pending marketing applications mentioning the facility, and approval of an application may be contingent on a pre-approval inspection.
“Based on the success of the PAI of VP-102 at Sterling and our understanding that the division was prepared to release our label, we believe that our NDA meets statutory standards for approval and that any issues at Sterling have not impact on the manufacture, quality, efficacy, or safety of VP-102. However, we recognize that the hands of the Dermatology Division may be tied due to re-inspection issues at Sterling and we thank them for their efforts with us to date,” said Ted White, President and CEO of Verrica, in a press release.
“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 in collaboration with the Agency,” added White.
VP-102 is a drug-device combination that allows precise topical dosing and targeted delivery of cantharidin. If approved, it could become the first FDA-approved product to treat molluscum contagiosum, a highly contagious skin disease that affects about six million people in the United States, mostly children. If Verrica gets the green light to sell in the United States, VP-102 will be marketed under the Ycanth brand.
Verrica will file a Type A meeting request with the FDA to clarify concerns and determine next steps to finally move its product forward. The company is also looking for an additional CMO to act as an alternate vendor.