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news.Galderma Laboratories has launched Soolantra (ivermectin) Cream, 1% , a once-daily, antibiotic-free, prescription topical treatment for rosacea patients in the US.
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The company noted that the FDA approved prescription treatment option is now available in pharmacies nationwide for patients with rosacea, a common, inflammatory disorder affecting the face.
The approval was based on data collected from more than 1,300 patients with moderate to severe inflammatory lesions of rosacea enrolled in two Phase III trials of a 12-week duration.
Additionally, in a separate head to head trial with metronidazole 0.75% cream, Soolantra Cream was shown to be more efficacious as early as week three.
In long-term extension trials, Soolantra Cream was safe and well-tolerated for up to 52 weeks, which is critical as rosacea patients have sensitive skin.
The company said that some study subjects experienced skin burning sensation and skin irritation while using Soolantra Cream.
Galderma consultant and clinical investigator for the Phase III studies of Soolantra Cream Linda Stein Gold said: "The availability of Soolantra Cream as a treatment for inflammatory lesions of rosacea offers a novel option to consider for my patients.
"Rosacea patients now have a powerful yet safe option that may work as fast as two weeks."
The cause of rosacea is unknown and research suggests that there are multiple triggers for the inflammation associated with the condition, including sun, alcohol, spicy food and exercise.