Adquey (difamilast 1%)<\/a> is a prescription ointment the FDA has approved for adults and for children 2 and older who have mild to moderate atopic dermatitis (AD), often called eczema. It is a nonsteroidal medicine that you put on the skin.<\/p>\nAD is a chronic inflammatory skin disease that is marked by ongoing inflammation, skin irritation, and persistent itching, along with recurrent rashes or lesions that may ooze, crust, or thicken over time. Abnormalities in certain skin barrier and immune-related proteins help start the symptoms and help stop them from going away. The severe itch that comes with the condition can interfere with sleep and substantially reduce quality of life. While treatments can provide relief for some patients, many continue to have flares and struggle to achieve clear skin and sustained itch control.<\/p>\n
Adquey works by blocking an enzyme called phosphodiesterase 4 (PDE4), which plays a role in skin inflammation and itching. By blocking PDE4, it can change cell signaling and lower certain inflammation signals in the skin. The exact way this leads to eczema relief is not fully known.<\/p>\n
As a new option within the nonsteroidal class, this approval provides another choice for the millions of people in the U.S. with eczema, offering a safer alternative to steroid medicine that can cause long-term side effects. This makes it suitable for regular or extended use, especially in children.<\/p>\n<\/section>\n\nWhy Was It Approved?<\/h2>\n
The FDA approval was supported by multiple clinical trials, which showed that Adquey helped significantly more patients with mild to moderate AD get clear or almost clear skin after four weeks, compared with those using a placebo.<\/p>\n
In the phase 3 studies, patients with mild to moderate AD applied either Adquey ointment or a placebo ointment twice daily for four weeks. The main goal at week four was “Investigator’s Global Assessment (IGA) success,” which means skin that is clear or almost clear with a large improvement from the start. Adquey helped more people reach that goal than the placebo.<\/p>\n
About 38.5% of people in one trial (ages 15 to 70 years) using Adquey reached the IGA success goal, compared with 12.6% using the placebo by week four. In another study involving children ages 2 to 14 years, 47.1% treated with Adquey achieved the IGA success, versus 18.1% with the placebo. Children using Adquey also showed greater improvements in Eczema Area and Severity Index (which indicates how severe eczema is overall), with benefits seen as early as the first week.<\/p>\n
Side effects in the studies were mostly mild to moderate. The most common was a mild cold (nasopharyngitis). Others included skin irritation where the medicine was applied, like rashes, small bumps, or mild infections.<\/p>\n<\/section>\n<\/div>\n
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\nWhat Do I Need to Know?<\/h2>\n
Adquey is for skin use only and should not be put into the eyes, mouth, or inside the vagina. A thin layer should be applied to the affected areas twice a day and rubbed in completely, while avoiding any areas of skin that look infected.<\/p>\n
It is approved for adults and children ages 2 years and older, with no listed contraindications.<\/p>\n
There is limited information about its use during pregnancy, and if you are breastfeeding, do not apply Adquey to the nipple or areola, and keep treated skin on your chest from touching your infant.<\/p>\n
Contact your health care provider if you notice unexpected skin changes or irritation that does not improve.<\/p>\n
The company plans to make Adquey available in the U.S. as soon as possible.<\/p>\n<\/section>\n<\/div>\n<\/div>\n
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