Novan's Berdazimer Gel, 10.3% and Verrica’s VP-102 (cantharidin 0.7% Topical Solution) have PDUFA dates coming up.

Thanks to a busy pipeline, treating molluscum contagiosum may get easier.

The U.S. Food and Drug Administration (FDA) accepted Novan’s New Drug Application (NDA) for Berdazimer Gel, 10.3% for the treatment of molluscum contagiosum with a Prescription Drug User Fee Act (PDUFA) goal date of January 5, 2024. In addition,  the FDA accepted Verrica’s resubmitted NDA for VP-102 (cantharidin 0.7% Topical Solution) with a PDUFA goal date of July 23, 2023.

It’s a race to the finish line. Either of these could be the first FDA-approved prescription product for molluscum contagiosum in the U.S.

In the B-SIMPLE phase 3 program, 1,598 patients were randomized to receive berdazimer gel 10.3% (n = 917) or a vehicle (n = 681) once daily for 12 weeks. Fully 30% of berdazimer gel-treated patients showed complete clearance, compared with19.8% of vehicle-treated patients.  These findings were presented at the 2023 meeting of the American Academy of Dermatology.

The gel is a potential first-in-class topical nitric oxide-releasing agent.

Novan completed the acquisition of EPI Health in early 2022, and EPI Health has now adopted Novan corporate branding, creating unified identity in advance of potential commercial launch of berdazimer gel, 10.3%.

Berdazimer gel, 3.4% (SB204), a topical monotherapy is also in Phase 3 clinical development for the treatment of acne.

The Bigger Picture

“Molluscom contagiosum has a particular predilection for kids with atopic dermatitis,” says Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago.

They are benign and do go away on their own, but these growths are bothersome and can be unsightly. Kids are also needlessly kept home from camp when they present with molluscom contagiosum.

The Berdazimer gel is mixed and applied at home, he explains. It can and may be used with the Verrica product.

“We can use VP-102 in the office and send the patient home with Berdazimer gel,” Dr. Lio says. “There’s no shortage of these patients, and if these get approved, every pediatrician will have something to write for kids.”