FDA approves prescription berdazimer gel, 10.3% to treat molluscum contagiosum

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Contemporary PEDS JournalJanuary/February 2024

Berdazimer gel, 10.3% demonstrated positive, topline data in the phase 3 randomized clinical B-SIMPLE4 trial (NCT04535531) that featured a total of 891 patients aged 6 months or older who had 3 to 709 raised molluscum contagiosum lesions.

FDA approves prescription berdazimer gel, 10.3% to treat molluscum contagiosum | Image Credit: © Calin - © Calin - stock.adobe.com.

FDA approves prescription berdazimer gel, 10.3% to treat molluscum contagiosum | Image Credit: © Calin - © Calin - stock.adobe.com.

Takeaways:

  • The FDA has approved Lingand Pharmaceuticals' prescription berdazimer gel, 10.3% (SB206), for the treatment of molluscum contagiosum, offering a new at-home treatment option.
  • The gel demonstrated positive results in the phase 3 B-SIMPLE4 trial, involving 891 patients aged 6 months or older with raised molluscum contagiosum lesions.
  • Patients applied the gel as a thin layer once daily for 12 weeks, resulting in a 32.4% complete clearance of lesions compared to 19.7% in the vehicle group.
  • Berdazimer gel, 10.3%, provides a new and safe option for molluscum contagiosum treatment, addressing the increasing incidence of the contagious skin disease.
  • Common adverse events included application-site pain and erythema, with mild to moderate erythema as the most frequent local skin reaction.

The FDA has approved Lingand Pharmaceuticals' prescription berdazimer gel, 10.3% (ZELSUVMI) to treat molluscum contagiosum approximately 9 months after the federal agency accepted a New Drug Application.1,2

The approval is indicated for adults and pediatric patients aged 1 year and up. According to a press release from Ligand, berdazimer gel, 10.3% is expected to be commercially available during the second half of 2024.1

The approval makes berdazimer gel, 10.3% the first topical prescription that can be applied to patients, parents, or caregivers outside of a medical setting.1

“[The Berdazimer gel, 10.3%] approval gives us 1 more tool to treat this frustrating, yet quite common, infectious condition,” Smita Aggarwal, MD, board-certified dermatologist, pediatric dermatologist, Medical Dermatology Associates of Chicago; assistant professor of Dermatology, Rush University Medical Center, Chicago, Illinois, told Contemporary Pediatrics.

“The fact that it can be applied at home will also open the doors to treatment for families who are unable to come to the office for their treatments, which are traditionally administered by a provider and often require multiple sessions for complete clearance, which is not only frustrating to patients but also costly,” added Aggarwal.

Berdazimer gel, 10.3% demonstrated positive, topline data in the phase 3 randomized clinical B-SIMPLE4 trial (NCT04535531) that featured a total of 891 patientsaged 6 months or older who had 3 to 709 raised molluscum contagiosum lesions.3

The novel topical nitric oxide-releasing medication was randomized to patients and applied as a thin layer to all lesions once per day for 12 weeks. Patients who did not receive berdazimer gel, 10.3% received vehicle gel.3

The trial was conducted in 55 clinics from September 1, 2020, to July 21, 2021, with a primary endpoint of complete clearance of all molluscum contagiosum lesions at week 12.3

According to results from the trial that were published in JAMA Dermatology, 444 patients received berdazimer gel and 447 received vehicle gel. In the intention to treat population 393 patients (88.5%) in the berdazimer group and 397 patients (88.8%) in the vehicle group had lesion counts performed at week 12.3

At that stage, 144 patients in the berdazimer group (32.4%) achieved complete clearance of molluscum contagiosum lesions compared to 88 patients (19.7%) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8 [P < .001]).3

“It gives us a new, safe option for treatment, but I would like to see the follow-up off treatment and vehicle for another 6 to12 weeks after the study was completed,” said Bernard Cohen, MD, professor of pediatrics and dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.

In July 2023, the FDA approved VP-102 (YCANTH; Verrica Pharmaceuticals) making it the first FDA-approved product to treat the contagious skin disease.4

“The FDA approvals for these 2 agents are meeting demand for more and better treatments for molluscum contagiosum, which has certainly increased in incidence over the last several years,” Aggarwal said.

The most common adverse events were application-site pain and erythema. Eighteen patients discontinued the study because of adverse events with the most common local skin reaction being mild to moderate erythema.3

“Many of my families initially take a watch and wait approach to treating their molluscum because they are unable to easily access providers who offer in-office treatments, which traditionally were the only treatment options available to them,” added Aggarwal.

“Now, more patients will be able to treat their molluscum early before lesions have a chance to spread and cause further complications.”

References:

  1. US Food and Drug Administration approves ZELSUVMI as a first-in-class medication for the treatment of molluscum contagiosum. Ligand Pharmaceuticals. Press release. January 5. Accessed January 5. 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. FDA accepts Novan’s NDA for berdazimer gel, 10.3$ for the treatment of molluscum contagiosum with a PDUFA goal date of January 5, 2024. Novan, Inc. March 7, 2023. Accessed January 4, 2024. https://www.globenewswire.com/news-release/2023/03/07/2622009/0/en/FDA-Accepts-Novan-s-NDA-for-Berdazimer-Gel-10-3-for-the-Treatment-of-Molluscum-Contagiosum-with-a-PDUFA-Goal-Date-of-January-5-2024.html
  3. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. August 1, 2022. Accessed January 4, 2024. https://pubmed.ncbi.nlm.nih.gov/35830173/
  4. Krewson C. FDA accepts NDA for berdazimer gel to treat molluscum contagiosum. Contemporary Pediatrics. March 7, 2023. Accessed January 4, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-nda-for-berdazimer-gel-to-treat-molluscum-contagiosum

Click here to read more from the January/February issue of Contemporary Pediatrics.

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