OR WAIT null SECS
The FDA is looking for more information regarding aspects of the chemistry, manufacturing, and controls process for the drug-device combination
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Verrica Pharmaceuticals for its New Drug Application for VP-102, an investigational, proprietary, drug-device combination for the treatment of molluscum contagiosum.
In the letter, the FDA notes it is looking for more information regarding aspects of the chemistry, manufacturing, and controls process for the drug-device combination. The agency is also seeking Human Factors validation. There were no clinical deficiencies identified in the Complete Response Letter.
Verrica Pharmaceuticals, a dermatology therapeutics company, will request a Type A meeting to discuss the issues presented in the Complete Response Letter and to learn the steps needed to resubmit the New Drug Application 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,” Ted White, president and chief executive officer of Verrica, said in a statement. “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.”
In 2 double-blind, phase 3 trials, CAMP-1 and CAMP-2, investigators evaluated VP-102 compared to placebo in patients at least 2 years old who were diagnosed with molluscum. The results demonstrated favorable safety, efficacy, and tolerability.
Results from CAMP-1 and CAMP-2 showed 46% and 54%, respectively, of those treated with VP-102 achieved complete clearance of all baseline and new molluscum lesions at the end of the trials compared to 18% and 13%, respectively, of those in the placebo groups (P <.0001).
There were no serious adverse events reported, while any adverse events noted by subjects were mild-to-severe local skin reactions.
“We look forward to providing updates on our progress toward resubmitting our (New Drug Application) for VP-102 as quickly as possible,” White said.
The company previously received a letter from the agency which mentioned deficiencies that precluded discussion of labeling and post-marketing requirements and commitments.