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Verrica Pharmaceuticals Receives FDA Letter Regarding VP-102 NDA, Indicating There Are Deficiencies That Preclude Discussion Of Labeling And Post-marketing Requirements/Commitments At This Time

WEST CHESTER, Pa., June 29, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (NASDAQ:VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring

Benzinga · -

WEST CHESTER, Pa., June 29, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (NASDAQ:VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced that, on June 24, 2020, the Company received a letter from the U.S. Food and Drug Administration (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. 

The requests include, but are not limited to, a specific request related to a potential safety issue with the applicator that could arise if the instructions for use were not properly followed. In response, the Company incorporated an additional user feature into the applicator to address that issue. The addition of that user feature, however, has affected human factors testing as well as requiring additional supportive stability data on the fully assembled device incorporating such feature. The Company believes that both its long-term and registration stability data with the ampule, and the as-submitted applicator, support significant shelf life and stability for VP-102.

The Company anticipates interactions with, and additional communication from, the FDA and intends to work with the FDA to resolve and address any items as quickly as possible. 

Notwithstanding the pandemic or the CMC-related requests that have arisen during the review cycle, the Company believes that the positive results from its two double-blind Phase 3 trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum indicates that VP-102 remains viable for FDA approval.