FDA Approves Galderma's Soolantra to Treat Rosacea

The FDA approved Galderma’s Soolantra (ivermectin) Cream 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. R Recent studies have further solidified that generally harmless microscopic Demodex mites may also be a culprit. These mites are normal inhabitants of everyone’s skin, but may appear in greater numbers on the faces of people with rosacea.

In clinical studies, Soolantra Cream effects were seen as early as week two with continuous improvement in patients with inflammatory lesions of rosacea. Furthermore, in a separate head-to-head study with metronidazole 0.75% cream—a current gold standard—Soolantra Cream was shown to be more efficacious from as early as week three onward. While the mechanism of action of Soolantra Cream is unknown, ivermectin, the active ingredient in Soolantra Cream, has been reported to have both anti-inflammatory and antiparasitic activity.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” said Linda Stein Gold, MD, Galderma consultant and clinical investigator for the Phase III studies of Soolantra Cream. “While some rosacea treatments for the common bumps and pimples of the condition may take more than four weeks to show effect, Soolantra Cream may provide initial results as early as week two.”

Rosacea is a chronic and progressive disease. If left untreated, it can worsen, and symptoms, like the inflammatory lesions of rosacea, may become more difficult to treat. In a national study of rosacea patients, 46 percent of sufferers reported that they changed their medication, usually due to lack of improvement. There is an ongoing need for patients and healthcare practitioners to have other effective treatment options for the condition.

The approval of Soolantra Cream was based on two pivotal Phase III multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies where Soolantra Cream met each of its co-primary efficacy endpoints. The onset of treatment effect was observed as early as week two with continuous improvement. In long-term extensions to the 12-week studies, Soolantra Cream was also safe and well-tolerated for an additional 40 weeks (up to 52 weeks in total), which is critical for rosacea patients who often have sensitive skin. Some study subjects experienced skin burning sensation and skin irritation while using Soolantra Cream.

“As a world leader in skin health, Galderma is committed to providing innovative treatment options for clinicians and patients, and the approval of Soolantra underscores these ongoing efforts,” said Stuart Raetzman, Chief Executive Officer of Galderma Laboratories, L.P. and Senior Vice President North America. “Our laser focus on skin health has helped us expand upon our rosacea franchise to continue to deliver medicines that offer novel approaches to help address important patient needs.”