The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum.
Berdazimer gel is an investigational nitric oxide-releasing topical antiviral gel. The application is supported by data from the pivotal phase 3 B-SIMPLE4 study (ClinicalTrials.gov Identifier: NCT04535531) that evaluated the efficacy and safety of berdazimer gel 10.3% applied topically once daily in 891 patients 6 months of age and older with molluscum contagiosum.
Findings from the trial showed that treatment with berdazimer gel met the primary endpoint achieving complete clearance of all treatable molluscum lesions at week 12 compared with vehicle gel. As for safety, berdazimer gel was well tolerated with no treatment-related serious adverse events reported. The most common adverse events reported were mild application site pain and mild to moderate erythema.
A Prescription Drug User Fee Act target date of January 5, 2024 has been set for this application.
FDA accepts Novan’s NDA for Berdazimer Gel, 10.3% for the treatment of molluscum contagiosum with a PDUFA Goal Date of January 5, 2024. News release. Novan. Accessed March 7, 2023. https://www.globenewswire.com/news-release/2023/03/07/2622009/0/en/FDA-Accepts-Novan-s-NDA-for-Berdazimer-Gel-10-3-for-the-Treatment-of-Molluscum-Contagiosum-with-a-PDUFA-Goal-Date-of-January-5-2024.html.