The federal agency gave the nod to Verrica Pharmaceuticals for its therapy, VP-102 (Ycanthe), for molluscum contagiosum (molluscum), making it the first treatment indicated for the viral-borne skin disease.
Molluscum contagiosum (molluscum) is a highly contagious viral skin disease that affects approximately 6 million people in the United States. It mainly affects children under the age of 16.
Yesterday, the FDA approved the first-ever treatment for this skin condition. Verrica Pharmaceuticals’ therapy, VP-102, was granted the approval and is indicated to treat molluscum in adults and children 2 years of age and older.1
Verrica developed this drug-device combination product with a controlled formulation of cantharidin (0.7% w/v) that is designed to be administered through a single-use applicator for topical dosing and targeted delivery.
“We are proud to bring patients and caregivers the first FDA-approved treatment for molluscum, which is one of the largest unmet needs in medical dermatology,” Verrica CEO Ted White, said in the accompanying statement. “Verrica is the first company to develop a proprietary applicator and GMP-formulation of cantharidin that allows a safe, effective and precise topical administration, and the first company to successfully gain FDA approval after conducting rigorous clinical trials to evaluate the safe and effective use of a cantharidin-based product for the treatment of molluscum."
The New Drug Application (NDA) for this new treatment had been backed by data from the CAMP-1 and CAMP-2 clinical trials, which had shown a substantially higher rate of complete clearance of molluscum lesions and reduction in lesion count compared to the control arm at 84 days (P <.0001).2
Additional post-hoc analyses of the CAMP trials showed that a statistically significant greater proportion of the VP-102 arm achieved complete lesion clearance than vehicle across all affected body regions, including areas deemed most sensitive.
During these 2 trials, certain adverse events were noted in some of the participants who had been given VP-102, including pruritus, blistering, pain, and erythema at the application site. No serious adverse events were reported by treated patients.3
The PDUFA date for the drug’s approval had been set in February of 2023 when Verrica Pharmaceuticals accepted the NDA for VP-102.
Verrica had initially submitted their application for VP-102 to the FDA for this specific indication in 2021, but they received a Complete Response Letter (CRL) as a result of observed deficiencies at a contract manufacturing organization facility that was not involved in the drug's production.
However, the CRL announcement by Verrica emphasized that the treatment’s safety, clinical, or manufacturing properties were not found to be deficient by the FDA at the time. Besides its current use for this indication, VP-102 is also being assessed in another 2 mid-stage clinical trials for the treatment of common warts and external genital warts.
Recent late-breaking phase 3 data from B-SIMPLE showed berdazimer gel 10.3% treatment led to about 75% improvement in complete lesion clearance compared to vehicle and, specifically among children aged 6 to <12 years old, a complete clearance rate of 31.1% complete clearance rate versus 14.0% at 12 weeks.4
These findings, presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans, demonstrate that VP-102 and topical berdazimer are the 2 most promising potential treatments for molluscum contagiosum among children and adults.
Last year, the company had received its CRL from the FDA citing manufacturing concerns. In the CRL, the FDA cited deficiencies identified at Sterling Pharmaceuticals Services, the contract manufacturing organization that produces VP-102. A pre-approval inspection (PAI) had been conducted at Sterling. Verrica said their NDA review was completed and they were set to be notified of their label, had it not been for Sterling’s Official Action Indicated (OAI) status.
At that time, Verrica was confident it would be able to meet the concerns of the CRL and move forward with the final approval. “Based on the successful PAI of VP-102 at Sterling and our understanding that the Division was ready to communicate our label, we believe our NDA meets the statutory standards for approval and that any issues at Sterling do not impact the manufacturing, quality, efficacy, or safety of VP-102,” said Ted White, Verrica’s president and CEO.
This article originally appeared on HCPLive's site.
1.Verrica Pharmaceuticals Announces FDA Approval of YCANTH™ (cantharidin) topical solution 0.7%. News release. Verrica Pharmaceuticals. Published July 21, 2023. https://verrica.com/press_release/verrica-pharmaceuticals-announces-fda-approval-of-ycanth-cantharidin-topical-solution-0-7/
2.Kunzmann, K. FDA Accepts New VP-102 Application for Molluscum Contagiosum. HCPLive. February 28, 2023. Accessed July 23, 2023.
3.Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum. News release. Verrica Pharmaceuticals. February 27, 2023. https://verrica.com/press_release/fda-accepts-resubmitted-filing-for-vp-102-for-the-treatment-of-molluscum-contagiosum/
4.Browning J et al. Efficacy of Berdazimer Gel 10.3% in the Treatment of Molluscum Contagiosum: Integrated Results from the B-SIMPLE Phase 3 Program. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17 – 21. New Orleans, LA. Accessed March 18, 2023.