Drugs Xagena
Epiduo Forte ( Adapalene and Benzoyl peroxide ) Gel, 0.3%/2.5% has been approved by the FDA ( Food and Drug Administration ) for the once-daily, topical treatment of acne vulgaris.
Epiduo Forte Gel offers patients and physicians a unique treatment that combines two antibiotic-free medicines in one gel and is proven to control moderate to severe inflammatory acne. Left untreated, inflammatory acne may lead to long-term, skin-health issues including scarring. With the highest-available concentration of the retinoid Adapalene combined with Benzoyl peroxide, Epiduo Forte Gel helps treat moderate to severe inflammatory acne, by reducing the inflammation and redness associated with acne, and by unclogging pores and killing bacteria under the skin.
Epiduo Forte Gel can help to simplify the management of hard-to-treat acne, being a 2-in-1 combination product that comes in an easy to use pump for the treatment of acne on the face, chest, back or shoulders.
The approval of Epiduo Forte Gel was based on a pivotal phase 3, multicenter, randomized, double-blind, 12-week, placebo-controlled study in which it met each of its primary efficacy endpoints when compared to placebo gel in 217 acne subjects. The study demonstrated superiority of Epiduo Forte Gel over placebo gel ( 33.7% vs 11.0% ) in the overall study population ( moderate to severe ) at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory ( -68.7% vs -39.2% ) and non-inflammatory lesion count ( -68.3% vs -37.3%, respectively ) ( all P less than 0.001 ). Additionally, subjects who were severe at baseline ( 50% ) were required to go from severe to clear or almost clear within the 12-week trial to be considered a treatment success. More than half of study subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne ( 50.5% ).
In the pivotal study of subjects with moderate to severe acne, Epiduo Forte Gel results were seen as early as one week, and more than 90% of subjects reported complete, significant or moderate improvement in their acne by week 12.
Epiduo Forte Gel was shown to be safe, well tolerated, and can be considered for long-term use. Some study subjects ( greater than or equal to 1% ) experienced skin irritation, eczema, atopic dermatitis and skin burning sensation while using Epiduo Forte Gel.
Acne is the most common skin condition in the United States, affecting more than 40 to 50 million people. Acne appears when pores clog with dead skin cells, and can have a wide-ranging negative impact on sufferers that includes both emotional and physical scars. Studies show that many people who have acne suffer from low self-esteem and depression.
Acne not only affects teenagers but also can be seen in men and women of all ages with research showing that the onset of acne is frequently seen in prepubescent patients.
When it comes to acne treatment, long-term use of antibiotics may be a contributing factor to the overall global antibiotic resistance issue. Propionibacterium acnes, a bacteria linked to acne, is increasingly becoming resistant to topical and oral antibiotics, which may potentially cause a decrease in treatment efficacy against acne. ( Xagena )
Source: Galderma, 2015
XagenaMedicine_2015
