FDA Approves Berdazimer Topical Gel as First Treatment for Molluscum Contagiosum

The FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi; Ligand Pharmaceuticals Inc) for the treatment of molluscum contagiosum in individuals aged 1 year and older. This approval makes the first novel drug for this indication, according to a press release.¹

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“The approval of [berdazimer topical gel] is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient, or a family member,” Mark D. Kaufmann, MD, FAAD, a clinical professor of dermatology in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in the press release. “I look forward to having this novel medication to treat my molluscum patients.”¹

Berdazimer topical gel is the first and only topical prescription medication that can be applied at home by patient or caregiver, without a physician or in other medical settings. It is a nitric oxide releasing agent, which has been shown to have antiviral properties. However, according to the press release, the mechanism of action for the treatment of molluscum contagiosum is unknown, but the efficacy of berdazimer topical gel was shown to reduce lesion counts.¹

In 2 phase 3 trials, B-SIMPLE 4 and B-SIMPLE 2, the results showed the drug was well tolerated when used once a day. The trials were included in the B-SIMPLE phase 3 program, which enrolled 1598 individuals.¹

The B-SIMPLE 4 trial was conducted across 55 clinics, which were mainly dermatology and pediatric focused, in the United States from September 1, 2020, to July 21, 2021. Individuals included were aged 6 months and older who had 3 to 70 raised molluscum contagiosum lesions. Individuals with sexually transmitted molluscum contagiosum and those with molluscum contagiosum only in the periocular area were excluded, according to the study authors.²

Investigators randomized treatment with either berdazimer topical gel or vehicle gel among individuals and it was 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.²

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, according to the study authors.²

The most commonly reported adverse reactions included application site reactions such as pain, burning, and stinging sensations, erythema, pruritus, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, and infection, according to the press release.¹

“It is nice to see that molluscum contagiosum is finally getting the attention it deserves. For those of us in the primary care field, it is wonderful to have an effective option that can be used at home rather than taking a wait and watch approach,” Stephen W. Stripling, MD, pediatrician at Coastal Pediatrics Associates, said in the press release.¹

Berdazimer topical gel is expected to be available in the United States in the second half of 2024, according to the press release.¹

References

1. US Food and Drug Administration approves Zelsuvmi as a first-in-class medication for the treatment of molluscum contagiosum. News release. Ligand. January 5, 2024. Accessed January 9, 2024. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx
2. Browning JC, Enloe C, Cartwright M, Hebert A, 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. doi:10.1001/jamadermatol.2022.2721