Positive outcome of European Decentralised Procedure for approval of Soolantra cream 10 mg/g for rosacea
Soolantra ( Ivermectin ) cream 10mg/g for the once-daily topical treatment of inflammatory lesions of papulopustular rosacea in adult patients was granted a positive outcome as part of a European decentralised procedure.
The marketing authorisation application of Soolantra cream was based on three phase III studies, which involved over 2,300 subjects.
Two 12-week treatment vehicle-controlled studies demonstrated superiority of Soolantra cream efficacy over vehicle cream within 4 weeks.
In a 16-week treatment active-controlled study, Soolantra Cream was shown to be superior to Metronidazole 7.5 mg/g cream twice-daily in reducing inflammatory lesion counts ( ILC ) as of week 3 and until week 16.
After 16 weeks of treatment with Soolantra, the reduction in ILC reached 83.0% from baseline.
While the Soolantra cream mechanism of action is not completely understood, Ivermectin, its active ingredient, has been reported to have both anti-inflammatory and anti-parasitic properties.
There are currently few effective treatments that reduce the papules and pustules of rosacea, and these may take in excess of four weeks to show results.
Soolantra cream has demonstrated a quick onset and improved efficacy over an existing reference treatment in clinical studies, making it a new therapeutic option that meets the needs of rosacea patients.
Rosacea is a common inflammatory skin disease that presents variable clinical characteristics, of which the most common are flushing, permanent erythema, papules and pustules. It mainly affects the central areas of the face, such as the cheeks and nose. The disease affects both adult men and women, usually after the age of 30.
Additionally, symptoms such as stinging, burning and increased sensitivity of the skin are common, and in some cases the eyes can become red, dry and itchy.
Although the cause of the disease is still under debate, various trigger factors are known, including spicy foods, alcohol, emotional stress, sun/UV-exposure, hot baths and beverages.
Demodex, generally harmless mites, can also be found in the skin in an elevated quantity in people with rosacea.
Rosacea may worsen over time if left untreated. ( Xagena )
Source: Galderma, 2015