The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.
Cantharidin is a blistering agent that has been used since the 1950s to treat molluscum contagiosum and warts. It was removed from the market in 1962 after the FDA required manufacturers to submit efficacy data for their products. VP-102 is a drug-device combination product that delivers cantharidin (0.7% w/v) via a single-use applicator.
Results from both trials showed a clinically and statistically significant number of patients treated with VP-102 achieved complete clearance of all treatable molluscum lesions (primary end point). VP-102 was also found to be well tolerated with no serious adverse events.
While no clinical issues were noted in the Complete Response Letter issued in September 2021, the Agency did identify deficiencies at a facility of a contract manufacturing organization, which the Company has since addressed.
“We are pleased that the FDA has accepted our NDA resubmission for VP-102,” said Ted White, Verrica’s President and CEO. “While we recognize the demands of the Agency’s current workload, we intend to work with the FDA toward approval as quickly as possible based on the limited changes in our resubmission.”
A Prescription Drug User Fee Act (PDUFA) target date of May 24, 2022 has been set for the application.
- Verrica Pharmaceuticals announces acceptance by FDA of NDA resubmission for VP-102 for the treatment of molluscum contagiosum. News release. Verrica Pharmaceuticals Inc. Accessed December 15, 2021. https://www.globenewswire.com/news-release/2021/12/15/2353095/0/en/Verrica-Pharmaceuticals-Announces-Acceptance-by-FDA-of-NDA-Resubmission-for-VP-102-for-the-Treatment-of-Molluscum-Contagiosum.html.
- 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. News release. Verrica Pharmaceuticals Inc. September 20, 2021. Accessed December 15, 2021. https://verrica.com/press_release/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-mo/.