Pelthos Therapeutics Inc. is officially launching berdazimer topical gel, 10.3% (Zelsuvmi) for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older.
The gel, which received a Novel Drug designation from the U.S. Food and Drug Administration in January 2024, is the first and only prescription therapy approved for use at home by patients, parents, and caregivers to treat molluscum infections.
Zelsuvmi is a novel, topical nitric oxide-releasing gel for the treatment of molluscum at the time of diagnosis. The once-daily prescription medication can be used to treat infections on the body, including sensitive areas such as the face, groin, or underarms.
Zelsuvmi is now commercially available through retail pharmacies, ASPN pharmacy services, and for at-home delivery through mail-order pharmacies via prescription.
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group, Phase 3 study established the efficacy and safety of Zelsuvmi in 891 patients. Complete clearance of molluscum lesions was seen in nearly 33% of patients compared with 19.7% of patients who did not receive the active ingredient at the 12th week. For many patients, Zelsuvmi demonstrated results within two weeks.
“Many parents delay seeking treatment for their children’s uncomfortable lesions because current procedural treatments and frequent office visits can be inconvenient, while therapeutic options are limited. Untreated molluscum can spread throughout the child’s body but also to other family members,” says Nanette Silverberg, MD, Chief of Pediatric Dermatology at the Mount Sinai Health System in New York, NY. “A safe and effective topical gel for molluscum, like Zelsuvmi, which can be applied at home or on the go, would make a significant difference for this young patient population and address a serious, unmet medical need.”
The Company is also launching ZelsuvmiGo, a patient support program to help onboard patients and provide resources for caregivers.
