Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102.
The first CRL was distributed in July 2020 as the FDA requested additional details on certain aspects of the chemistry, manufacturing and controls (CMC) process and Human Factors validation. The regulator did not pinpoint any clinical deficiencies at the time, but the issues raised affected discussions on post-marketing requirements and commitments for the drug-device.
While Verrica adhered to what was asked and resubmitted its NDA, VP-102 was once again issued a CRL in September 2021. The FDA identified some concerns at a facility of a contract manufacturing organization (CMO) which, while not directly related to the production of VP-102, heightened general quality concerns about the location.
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