Berdazimer gel, 10.3% from Novan, Inc., significantly out-performed placebo for the treatment of molluscum, according to results of the B-SIMPLE 4 pivotal Phase 3 clinical study published in JAMA Dermatology. Berdazimer gel, 10.3% is a potential first-in-class topical nitric oxide-based prescription treatment.

"Results from the B-SIMPLE 4 clinical study strongly demonstrate the promise of berdazimer gel, 10.3% as a potential first and only prescription medication for molluscum. The ability for the patient/caregiver to apply a nitric oxide-releasing topical gel to lesions that facilitates complete clearance is a breakthrough in molluscum treatment since many go untreated due to limited options. These study results also showed favorable tolerability which is a key factor in treating children," says Adelaide Herbert, MD, Chief of Pediatric Dermatology at McGovern School of Medicine and Children's Memorial Hermann Hospital.

In the Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4 multicenter, vehicle-controlled, double-blind study, 891 patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. Study participants were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions, compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema.

Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of those on active treatment achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of those receiving vehicle only. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a ≥90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients.

"If approved,  berdazimer gel 10.3% could offer pediatricians a way to initiate molluscum treatment with a topical prescription. Unlike current molluscum treatments, like cantheradin or curettage, which often require more than one in-office application, berdazimer could provide molluscum patients or their caregivers the ease of self-applying the gel on the lesions," says Stephan W. Stripling, MD, Co-Medical Director, Coastal Pediatric Research, Charleston, SC.

Novan says it plans to submit a New Drug Application for berdazimer gel, 10.3% to FDA before the end of this year.   

There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that if approved, topical berdazimer gel, 10.3% as a prescription, self- or caregiver-applied therapy would satisfy an important patient care need for the treatment of molluscum.