Novan submits new drug application for berdazimer gel for molluscum contagiosum treatment
Novan has submitted a new drug application to the FDA for the marketing authorization of berdazimer gel 10.3% for the treatment of molluscum contagiosum, according to a company press release.
The company submitted the application for this self-administered, topical nitric oxide-releasing agent on Jan. 6. If the filing is accepted, Novan anticipates a potential FDA approval in the first quarter of 2024, according to the release.
“Today marks a significant milestone for Novan and the culmination of substantial efforts of the entire Novan team — the company’s first NDA submission,” Paula Brown Stafford, president and CEO of Novan, said in the press release. “I am extremely proud of our team and the progress thus far with berdazimer gel 10.3%. ... The NDA submission brings Novan closer to providing what could be the first FDA-approved prescription product for the treatment of this contagious viral skin infection.”
According to the release, the submission is based on results from Novan’s 12-week, phase 3 B-SIMPLE4 clinical trial evaluating the safety and efficacy of berdazimer gel in 891 participants aged 6 months and older with molluscum contagiosum. Results showed complete lesion clearance by week 12 in 32.4% of berdazimer-treated patients compared with 19.7% of vehicle-treated patients. Mild application-site pain was the most commonly reported adverse event, with moderate erythema being the most common localized skin reaction.