FDA accepts berdazimer gel new drug application for molluscum contagiosum

The FDA has accepted a new drug application for Novan’s berdazimer gel for the treatment of molluscum contagiosum, the company announced in a press release.

Berdazimer gel 10.3% (SB206), which releases nitric oxide upon application and has an antimicrobial effect, showed complete clearance of molluscum in 32.4% of patients after 12 weeks in clinical trials.

If approved, berdazimer gel will be the first FDA-approved prescription treatment for molluscum contagiosum, a viral skin infection that affects approximately 6 million people, mostly children, each year.

“The opportunity for our [new drug application] to be approved in less than 10 months from today marks a significant and important milestone for Novan and its shareholders. We believe our [new chemical entity] can provide a much-needed therapeutic option for molluscum patients with the added benefit of being an easily applied, topical, self-administered treatment,” Paula Brown Stafford, MPH, president and CEO of Novan, said in the release. “We are thrilled that the FDA determined our application is sufficiently complete, no filing review issues were identified, and that the substantive review process has commenced.”

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