Berdazimer sodium, sold under the brand name Zelsuvmi, is a medication used for the treatment for molluscum contagiosum.[1] Berdazimer sodium is a nitric oxide releasing agent.[1] It is a polymer formed from sodium 1-hydroxy-3-methyl-3-(3-(trimethoxysilyl)propyl)-1-triazene-2-oxide and tetraethyl silicate.[3]
The most common side effects occurred at the drug application site including pain, rash, itch, eczema, swelling, erosion, discoloration, blister, irritation, and infection.[2] Other common side effects included fever, vomiting, and upper respiratory infections (common cold).[2]
Berdazimer sodium was approved for medical use in the United States in January 2024.[4][5][6]
Medical uses
Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum.[1]
Pharmacology
Mechanism of action
Berdazimer sodium is a nitric oxide releasing agent.[1] The mechanism of action for the treatment of molluscum contagiosum is unknown.[1]
History
The US Food and Drug Administration (FDA) approved berdazimer sodium based on evidence from three clinical trials (NI-MC301, NI-MC302, and NI-MC304) of 1,598 participants with molluscum contagiosum.[2] The trials were conducted at 121 sites in the United States.[2] Among the 1,598 enrolled participants, all of them were evaluated for efficacy and 1,596 were evaluated for safety.[2] In all three trials, participants with molluscum contagiosum were randomized to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks.[2] Efficacy was assessed as the proportion of participants achieving complete clearance at week twelve.[2] Complete clearance was defined as the subject having a total of molluscum contagiosum lesion count of zero at assessment.[2] Trial 1 enrolled 891 participants, trial 2 enrolled 355 participants, and trial 3 enrolled 352 participants.[1] Participants were randomized 1:1 in trial 1, and 2:1 in trials 2 and 3 to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks.[1]
Society and culture
Legal status
Berdazimer sodium was approved for medical use in the United States in January 2024.[2][5]
^World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
Further reading
Pera Calvi I, R Marques I, Cruz SA, Mesquita YL, Padrao EM, Souza RM, et al. (2023). "Safety and efficacy of topical nitric oxide-releasing berdazimer gel for molluscum contagiosum clearance: A systematic review and meta-analysis of randomized controlled trials". Pediatric Dermatology. 40 (6): 1060–1063. doi:10.1111/pde.15419. PMID37721050. S2CID262045499.
Han H, Smythe C, Yousefian F, Berman B (February 2023). "Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review". Journal of Drugs in Dermatology. 22 (2): 182–189. doi:10.36849/JDD.7230. PMID36745361. S2CID256613906.
Clinical trial number NCT04535531 for "A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)" at ClinicalTrials.gov
Clinical trial number NCT03927703 for "A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC (B-SIMPLE2)" at ClinicalTrials.gov
Clinical trial number NCT03927716 for "A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)" at ClinicalTrials.gov
