ZELSUVMI offers proven efficacy1,2
FDA-GUIDED PRIMARY END POINT:
Percentage of patients who achieved complete clearance of molluscum lesions at Week 121,2*
COMPLETE CLEARANCE
32.4%
ZELSUVMI
(n=144/444)
P<.001
19.7%
Vehicle
(n=88/447)
ZELSUVMI was applied during study visits at baseline and Week 2, 4, 8, and 12, and at home on other days. If all lesions were cleared at a study visit, the patient’s treatment period ended, and they were followed for recurrence or appearance of new lesions for an additional 12 weeks (24 weeks total).2
KEY SECONDARY END POINTS:
Almost 2x as many patients treated with ZELSUVMI experienced a complete or near complete response at Week 122
43.0% of the ZELSUVMI group vs 23.9% of the vehicle group achieved 90% or greater clearance of molluscum lesions2
43.5% of the ZELSUVMI group vs 24.6% of the vehicle group had 0 or 1 remaining molluscum lesions2
ZELSUVMI showed significantly greater decreases from baseline in molluscum lesion count vs vehicle2†
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*At Week 12, 88.5% (393/444) of patients in the ZELSUVMI group and 88.8% (397/447) in the vehicle group had a lesion count performed. Nonresponder imputation was used for missing values.2
†Significance shown at Week 4 based on the prespecified secondary end point definition, which was percent change from baseline in the number of lesions at Week 4.2
INDICATION
ZELSUVMI is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 1 year of age and older.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling, or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence ≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). Other adverse reactions include pyrexia (2.2%), vomiting (1.3%), and upper respiratory tract infection (1.2%).
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with use of ZELSUVMI in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of berdazimer in human or animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZELSUVMI and potential adverse effects on the breastfed child.
Pediatric: The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may request medical information and report adverse events or product complaints to Pelthos Inc. by calling 1-855-330-7546 or sending an email to medinfo@pelthos.com.
Please see the full Prescribing Information and Instructions for Use for ZELSUVMI.
References: 1. ZELSUVMI Package Insert. EPIH SPV, LLC. 2024. 2. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878.