FDA letter sent to Verrica Pharma notes deficiencies in the NDA for VP 102 to treat molluscum contagiosum.

Verrica Pharmaceuticals Inc. announced that the Company received a letter from the FDA as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for VP 102 (cantharidin 0.7% topical solution), Verrica’s lead product candidate for the treatment of molluscum contagiosum.

The letter states that there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter further states that the notification does not reflect a final decision on the information under review.

In a letter dated November 26, 2019, the FDA had assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 13, 2020 for completion of its review of the NDA. The FDA’s letter does not identify any specific items. But, the Company notes that information requests from the FDA during the NDA review have focused on CMC aspects of the drug-device combination. Verrica’s ability to address these CMC-related requests, however, was significantly impacted in large part by the COVID-19 pandemic.