FDA Approves At-Home Treatment for Highly Contagious Viral Skin Infection

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Also called water warts, molluscum contagiosum affects about 6 million Americans each year, most of whom are children.

The first ever at-home treatment for molluscum contagiosum, a highly contagious, viral skin infection mainly affecting children, is now available, thanks to a new approval by the U.S. Food and Drug Administration (FDA).

Molluscum contagiosum is relatively common in children but can also affect adults. It is characterized by round, firm, painless bumps that range in size from a pinhead to a pencil eraser. They can sometimes be painful or itchy. When scratched or removed, they often start to bleed. The bumps are usually located on a child’s face, trunk, arms, or legs. Sometimes, the bumps occur on the genitals, lower abdomen, or inner thighs of adults if it is transmitted through sexual intercourse. The infection spreads through direct skin-to-skin contact, especially if the bumps are scratched and open up. The virus can also be passed indirectly through swimming pools, toys, razors, or tattoo supplies. Left untreated, the bumps can last between six months and two years.

Molluscum contagiosum, also called water warts, affects about 6 million Americans each year, most of whom are children. However, roughly 73 percent of those affected go untreated.

The new treatment—Zelsuvmi, from Ligand Pharmaceuticals—comprises a nitric oxide-releasing agent with antiviral properties. While Zelsuvmi’s mechanism agent is unknown, trials have shown that the medication reduced the number of bumps in patients when used once a day, according to the manufacturer’s press release. The most commonly reported side effects include skin reactions at the application site, such as allergic dermatitis.

“The approval of Zelsuvmi is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient, or a family member,” Dr. Mark D. Kaufmann, a clinical professor of dermatology in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York and former president of the American Academy of Dermatology, said in the press release. “I look forward to having this novel medication to treat my molluscum patients.”

The approval of Zelsuvmi, the first new drug to be approved in 2024, comes on the heels of a July 2023 approval of a physician-administered medication consisting of a single-use applicator of cantharidin, a natural toxin produced by the blistering beetle. Cantharidin has been used by the Chinese for thousands of years to treat myriad illnesses and has been used since the 1950s to treat warts. The FDA removed it from the U.S. market in 1962 after the agency began requiring manufacturers to submit efficacy data.

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Other treatment options for molluscum contagiosum include retinoic ace or benzoyl peroxide, which irritate the sores; medication that blisters the bumps so they come off the skin; and scraping, freezing, or laser therapy, not often a viable therapy option for people with weak immune systems.

“It is nice to see that molluscum contagiosum is finally getting the attention it deserves. For those of us in the primary care field, it is wonderful to have an effective option that can be used at home rather than taking a wait and watch [sic] approach,” said Dr. Stephen W. Stripling, a pediatrician, study investigator, and molluscum researcher.

Zelsuvmi is expected to be available on the market in the second half of 2024, according to the company’s press release.

“We are proud of the team’s accomplishment, having completed the world’s largest clinical program in molluscum to bring this first-in-class topical medication to FDA approval,” said Todd Davis, CEO of Ligand. “Pediatricians, dermatologists, and caregivers have long-sought a convenient approach to treat this highly contagious skin infection. With Zelsuvmi, patients now have an at-home treatment option available.”

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