The Food and Drug Administration (FDA) has recently received a new drug berdazimer gel 10.3%, for treating molluscum contagiosum (MC). If it gets accepted, the topical product might receive its approval in the first quarter of 2024. Additionally, it will emerge as the first-in-class topical treatment for MC. MC represents the common, contagious viral skin infection that concerns about 6 million individuals in the United States each year, mostly children aged 1 to 14 years. Still, there are no FDA-approved therapies for this condition, which causes unsightly lesions on the face, trunk, limbs and axillae that may persist untreated for years.

Berdazimer gel 10.3% contains berdazimer sodium, a nitric oxide-releasing agent. Alongside, the manufacturer company is also developing a 3.4% formulation for the topical treatment of acne. Its FDA approval relies on data from the B-SIMPLE4 study, a phase 3 randomized trial that enrolls about 900 individuals with MC aged 6 months and older, with 3 to 70 raised lesions. Participants received treatment with either berdazimer gel 10.3% or a vehicle gel, to be applied in a thin layer to all lesions once daily for 12 weeks. The study looked for the absolute clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group versus 19.7% of those in the vehicle group achieved this outcome. Both groups observed lower side effects. 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events causing discontinuation of treatment. The common adverse events noted were application-site pain and erythema, most of which were mild or moderate.

Source: MD edge [Internet]. Berdazimer gel under review at FDA for treating molluscum contagiosum. 2023. Available from: https://www.mdedge.com/dermatology/article/260511/infectious-diseases/berdazimer-gel-under-review-fda-treating-molluscum