Pelthos Therapeutics Launches ZELSUVMI™, the First FDA-Approved At-Home Molluscum Treatment

Pelthos Therapeutics Inc., a company specializing in developing innovative treatment options, has announced the release of ZELSUVMI™ (berdazimer) topical gel, 10.3%, designed for treating molluscum contagiosum. This condition is a highly infectious viral skin disease affecting primarily children, with an estimated 16.7 million cases and 6 million new cases annually in the United States. Molluscum contagiosum presents as raised, flesh-colored or red bumps on the skin and can spread through contact with infected individuals or objects.

ZELSUVMI, which received Novel Drug designation from the U.S. Food and Drug Administration in January 2024, is the first approved treatment that can be used at home. It provides a convenient option for patients, parents, and caregivers. Scott Plesha, CEO of Pelthos, emphasized the significance of this launch, noting that previously, patients had limited at-home treatment options. The medication is now available through retail and mail-order pharmacies.

ZELSUVMI is a once-daily gel that releases nitric oxide, offering an effective and well-tolerated treatment for molluscum. This medication can be applied to various body parts, including sensitive areas like the face and underarms. The drug's efficacy was demonstrated in a large, randomized clinical trial involving 891 patients. The study, which was double-blind and vehicle-controlled, showed that nearly 33% of those treated with ZELSUVMI experienced complete clearance of lesions by the twelfth week, compared to 19.7% of patients who received a placebo. Positive results were evident for many patients within just two weeks.

Dr. Nanette Silverberg, Chief of Pediatric Dermatology at the Mount Sinai Health System, highlighted the challenges faced by parents in treating molluscum contagiosum. Many avoid seeking treatment due to the inconvenience of office visits and limited therapeutic options. Without treatment, molluscum can spread across the child's body and to family members. Dr. Silverberg believes that ZELSUVMI offers a safe and effective solution that can be conveniently applied at home.

Pelthos has also introduced the ZelsuvmiGo patient support program to assist in the seamless onboarding of patients and provide resources for caregivers. Sai Rangarao, Chief Commercial Officer at Pelthos, announced the hiring of 50 sales territory managers to collaborate with physicians who treat a high volume of molluscum patients. The company has also initiated digital outreach efforts to ensure widespread prescription accessibility.

Molluscum contagiosum, caused by a poxvirus, is a common skin infection affecting many individuals, particularly those with weakened immune systems. About 20% of HIV patients are impacted by this condition. The infection is easily spread through contact with infected persons or contaminated objects such as towels and toys. Lesions caused by molluscum can persist for months or even years, leading to discomfort, social stigma, and complications like bacterial infections from scratching. Estimates suggest that 30% of children with molluscum have lesions lasting beyond 18 months, and up to 73% go untreated.

ZELSUVMI, developed using the proprietary nitric oxide-based technology platform NITRICIL™, represents a significant advancement in the treatment of this condition. The gel's development and commercial launch reflect Pelthos Therapeutics' commitment to addressing unmet medical needs with safe and effective therapeutic solutions.