Verrica Pharmaceuticals has received a complete response letter from the FDA identifying deficiencies at a manufacturing facility for VP-102.
Verrica Pharmaceuticals, a dermatology therapeutics company, announced that the FDA has issued a Complete Response Letter (CPL) regarding its New Drug Application (NDA) for VP-102 (Verrica Pharmaceuticals) for the treatment of molluscum contagiosum (molluscum).1
The Prescription Drug User Fee Act (PDUFA) date for the drug had been previously extended for the NDA by 3 months to September 23, 2021 to allow the FDA more time to review information submitted by Verrica in response to comments from the agency regarding a human factors study.
According to the CRL, the FDA identified failings at a facility of a contract manufacturing organization (CMO), that are not specifically related to VP-102 manufacturing but do raise questions on general quality issues at the facility.
Before the CRL, the company had not been notified of any deficiencies at the CMA specifically related to VP-102 manufacturing or how this general investigation of the facility would have on the company’s NDA. The FDA did not identify any clinical, safety, or product specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.1
The CMO has implemented corrective actions to address the FDA’s concerns, according to Verrica, and the CMO has told Verrica that in the next 30 business days they expect to have resolved all the deficiencies up to FDA satisfaction standards.
During this 30 days, Verrica will work with the FDA to show the manufacturing practices, controls, and processes to ensure that any deficiencies at the CMO do not impact the efficacy, safety, or quality of VP-102.
“We remain confident that we have a path forward for VP-102 as a potential treatment option for molluscum, a highly contagious viral skin disease affecting approximately 6 million people in the United States, primarily children, for which there are currently no FDA-approved treatments,” said Ted White, president and CEO of Verrica, West Chester, Pennsylvania.
1. Verrica pharmaceuticals receives complete response letter from the FDA identifying deficiencies at a facility of a contract manufacturer for its new drug application for vp-102 for the treatment of molluscum contagiosum. GlobeNewswire News Room. Published September 20, 2021. Accessed September 20, 2021. https://www.globenewswire.com/news-release/2021/09/20/2300107/0/en/Verrica-Pharmaceuticals-Receives-Complete-Response-Letter-from-the-FDA-identifying-deficiencies-at-a-facility-of-a-Contract-Manufacturer-for-its-New-Drug-Application-for-VP-102-for.html