Exhibit 99.1
Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New
Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
– Complete Response Letter Requests Additional Chemistry, Manufacturing, and Controls
(CMC) and Human Factors Information –
– No Clinical Safety or Efficacy Issues Identified –
– Conference Call and Webcast Today at 8:30 a.m. ET –
WEST CHESTER, Pa., July 14, 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 the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for VP-102, the Company’s investigational, proprietary, drug-device combination for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed receipt of a letter from the FDA in which the agency noted deficiencies that precluded discussion of labeling and post-marketing requirements/commitments.
According to the CRL, the FDA is seeking additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation. Importantly, the FDA did not identify any clinical deficiencies. The Company plans to request a Type A meeting to discuss the issues that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for VP-102.
“We are confident that we can work closely with the FDA to fully address the issues raised in the letter and we continue to believe VP-102 remains viable for FDA approval,” said Ted White, President and Chief Executive Officer, Verrica. “We are unwavering in our commitment to the millions of patients and families with molluscum, and are dedicated to ultimately gaining FDA approval of VP-102. We look forward to providing updates on our progress toward resubmitting our NDA for VP-102 as quickly as possible.”
Verrica believes that the positive results from its two double-blind Phase 3 trials (CAMP-1 and CAMP-2), which evaluated VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum, have demonstrated favorable safety, efficacy and tolerability. Specific results from the CAMP-1 and CAMP-2 studies showed that 46 and 54 percent, respectively, of subjects treated with VP-102 achieved complete clearance of all baseline and new molluscum lesions at the end of the trials (Day 84), versus 18 and 13 percent, respectively, of subjects in the vehicle groups (p<0.0001). There were no serious adverse events reported in VP-102-treated subjects, and most adverse events reported in subjects receiving VP-102 were local skin reactions and mild to moderate in severity.
