The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer announced on March 7.
If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.
Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, jual feldene trunk, limbs, and axillae that may persist for years if left untreated.
The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.
The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. At total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.
The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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