FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum

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The US Food and Drug Administration (FDA) has accepted Novan Inc.’s New Drug Application (NDA) filing for berdazimer gel, 10.3% for the treatment of molluscum contagiosum. The FDA has given Novan a Prescription Drug User Fee (PDUFA) goal date of January 5, 2024.¹

Novan submitted its NDA to the FDA in January of this year. The NDA submission was based on positive data from the phase 3 study of berdazimer gel, 10.3%, B-SIMPLE4 (NCT04535531). Berdazimer gel demonstrated statistically significant improvement in the primary endpoint of complete clearance of all treatable molluscum contagiosum at week 12. Berdazimer gel was reported to be well tolerated with mild application site pain and mild-to-moderate erythema reported as the most common adverse event.

Results from the B-SIMPLE4 trial were first published in the Journal of the American Medical Association Dermatology.² Study authors John C. Browning, MD, MBA, and colleagues noted “molluscum contagiosum infection is usually self-limited, yet may persist for months to years, generating a substantial health care burden and quality-of-life concerns necessitating therapeutic intervention. Treatment may also be warranted because of its highly contagious nature and concern for infecting peers or household members. Additionally, outwardly visible lesions may be associated with discomfort and psychosocial stigma, and may scar after resolution.”

Key secondary endpoints from B-SIMPLE4 included:²

• A lesion count of 0 or 1 of all treatable molluscum contagiosum at week 12
• A 90% reduction from baseline in the number of all treatable molluscum contagiosum at week 12
• Complete clearance of all treatable molluscum contagiosum at week 8
• Change from baseline in the number of all treatable molluscum contagiosum at week 4

Overall, Browning et al determined that “berdazimer gel, a novel topical nitric oxide–releasing medication, appears to demonstrate favorable efficacy and safety in patients with MC who are 6 months or older.”²

References

1. 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. Published March 7, 2023. Accessed March 7, 2023. https://novan.com/fda-accepts-novans-nda-for-berdazimer-gel-10-3-for-the-treatment-of-molluscum-contagiosum-with-a-pdufa-goal-date-of-january-5-2024/
2. 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(8):871–878. doi:10.1001/jamadermatol.2022.2721