General Information

Zelsuvmi (berdazimer) is a nitric oxide (NO) releasing agent.

Zelsuvmi is specifically indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.

Dosage/Administration

Zelsuvmi is supplied as a gel for topical administration.

• Zelsuvmi is supplied in a carton containing two tubes: Tube A containing berdazimer gel and Tube B containing hydrogel. Refer to “Instructions for Use” section of the drug label for detailed instructions on the preparation and administration of Zelsuvmi.
•  Mix together equal amounts of gel from Tube A and Tube B before application.
• Do not premix or store mixed Zelsuvmi.
•  Immediately apply Zelsuvmi as an even thin layer. Apply Zelsuvmi once daily to each MC lesion for up to 12 weeks.
• Wash hands after applying Zelsuvmi, unless hands are being treated.
• Allow Zelsuvmi to dry for 10 minutes after application.
•  Avoid application to uninvolved skin and avoid transfer of applied Zelsuvmi to other areas, including the eye.
•  Avoid swimming, bathing, or washing for 1 hour after application of Zelsuvmi.
• Zelsuvmi not for ophthalmic, oral, or intravaginal use. 

Mechanism of Action

Zelsuvmi (berdazimer) is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties. The mechanism of action for the treatment of molluscum contagiosum is unknown.

Side Effects

Adverse effects associated with the use of Zelsuvmi may include, but are not limited to, the following:

• application site reactions, including:

• pain
• erythema
• pruritus
• exfoliation
• dermatitis
• swelling
• erosion
• discoloration
• vesicles
• irritation
• infection

Clinical Trial Results

The FDA approval of Zelsuvmi was based on two phase 3 trials: hase 3 trials, B-SIMPLE 4 and B-SIMPLE 2, which were included in the B-SIMPLE phase 3 program, which enrolled 1598 individuals.

The B-SIMPLE 4 trial was conducted across 55 clinics and enrolled patients aged 6 months and older who had 3 to 70 raised molluscum contagiosum lesions. Patients were randomized to treatment with either berdazimer topical gel or vehicle gel applied as a thin layer to all lesions once daily for 12 weeks. The primary endpoint included the complete clearance of all lesions at week 12, with safety and tolerability measures including adverse event frequency and severity and assessment of local skin reaction and scaring. Investigators found that 32.4% of those in the berdazimer topical gel group achieved complete clearance of lesions compared with 19.7% of those in the vehicle group at week 12. Approximately 14.4% of individuals discontinued treatment due to clearance in the berdazimer topical gel group compared with 8.9% in the vehicle group.