By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The U.S. Food and Drug Administration (FDA) has approved the first and only prescription drug for the home treatment of molluscum contagiosum (MC). Berdazimer, administered with a hydrogel, is a nitric oxide-releasing agent with antiviral properties. It is formulated as a topical gel and will be distributed by EPIH SPV, LLC as Zelsuvmi.
INDICATIONS
Berdazimer is indicated for the topical treatment of MC in adults and pediatric patients 1 year of age and older.1
DOSAGE
Apply a thin, even layer once daily to each MC lesion for up to 12 weeks. The medication (10.3%) is dispensed as Tube A (14 grams of berdazimer gel) and Tube B (17 grams of hydrogel) which are mixed together (0.5 mL) and applied immediately.
POTENTIAL ADVANTAGES
Berdazimer is the first FDA-approved treatment for MC.
POTENTIAL DISADVANTAGES
Some subgroups, ages 12 to 18 years and African Americans, may not respond as well in terms of complete lesion clearance.2 The drug is approved for adults; however, it was studied primarily in those 2 to 17 years of age (96%). The most common adverse reactions (< 10%) are application site pain, which includes burning, stinging (18.7%), and erythema (11.7%).1
COMMENTS
The efficacy of berdazimer was evaluated in three randomized, double-blind, vehicle-controlled trials in subjects with MC.1-3 Trial 1 randomized 444 patients to berdazimer and 447 patients to vehicle.1,3 Respective numbers were 237 and 118 for trial 2 and 235 and 116 for trial 3. Overall, the mean age was 6.7 (± 4.6) years; 91% were ages 2 to 12 years, 88% were white, 51% were male, 40% had ≥ 20 lesions, and 64% had time since onset of more than 6 months. The primary efficacy endpoint was the percentage of subjects with complete clearance of all treatable lesions (lesion count of 0 at assessment) at week 12. Trial 1 achieved statistical significance, 32.4% vs. 19.7%. Eighty-two percent (322/392) of participants treated with berdazimer reported their MC lesions were very much improved or much improved compared to 60% (237/394) treated with the vehicle.4 Trials 2 and 3 did not achieve statistical significance in terms of complete lesion clearance (30% vs. 20.3% and 26% vs. 22%, respectively). When all three studies combined, the success rate was 30.0% vs. 19.8% (P < 001).2 Subgroup analysis suggests that subjects ages 6 to 12 years had the best response (31.1% vs. 14%) while those ages 12 to 18 years and Black/African American showed similar responses to the vehicle (34% vs. 32% and 26% vs. 26% respectively).2
CLINICAL IMPLICATIONS
MC is a common, benign, highly contagious, superficial (affecting the epidermis) skin disease caused by a poxvirus (Molluscipoxvirus).5 It is considered a pediatric (ages 1-14 years) disease that is self-limited, as papules usually disappear spontaneously within six to 12 months but may take longer (as long as four years).5 Lesions can range from 2 mm to 5 mm in diameter and can be anywhere on the body. They may be itchy, sore, red, or swollen. The virus can be spread from direct-to-person physical contact or through contaminated inanimate objects. Risk factors include those with weakened immune systems, atopic dermatitis, and individuals living in warm, humid conditions or crowded living conditions. Current treatment options include physical removal with cryotherapy and topical cantharidin administered by a healthcare professional.5 Berdazimer offers a new topical option with modest effectiveness in terms of complete lesion clearance but may provide meaningful partial lesion clearance. It is expected to be available mid-2024. Pricing has not yet been established.
REFERENCES
- Zwlsuvmi Prescribing Information. EPIH SPV LLC. January 2024. https://zelsuvmi.com/wp-content/uploads/2024/01/ZELSUVMI-Berdazimer-Topical-Gel-10.3.-Prescribing-Information-and-Instructions-for-Use.pdf
- Sugarman JL, Hebert A, Browning JC, et al. Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol 2024;90:299-308.
- 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;158:871-878.
- Browning JC, Cartwright M, Thorla I Jr, et al. A patient-centered perspective of molluscum contagiosum as reported by B-SIMPLE4 clinical trial patients and caregivers: Global Impression of Change and exit interview substudy results. Am J Clin Dermatol 2023;24:119-133.
- Centers for Disease Control and Prevention. Molluscum contagiosum. Last reviewed: May 11, 2015. https://www.cdc.gov/poxvirus/molluscum-contagiosum/index.html
