Novel Rosacea treatment approved by Health Canada for adult patients

Rosiver (Ivermectin) targets a microscopic mite commonly found on the skin

THORNHILL, ON, July 20, 2015 /CNW/ - Galderma Canada Inc. today announced the Health Canada approval of Rosiver (Ivermectin) Cream 1%, a once-daily topical treatment for inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older.¹  Rosacea is a common skin condition that affects more than two million Canadians.² It often presents as a redness, like a blush, appearing on the face, but may gradually appear on the ears, chest, back, and eyes.  Although the cause of rosacea is unknown, research suggests that there are multiple triggers for the inflammation associated with the condition, including sun, alcohol, spicy food and exercise.  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.

"Rosacea is a condition that has a dramatic impact on patients, although it is not something that is physically life threatening, it can present a significant emotional toll," says Dr. Melinda Gooderham, Dermatologist and Medical Director at the SKiN Centre for Dermatology in Peterborough, Ontario.  "The approval of Rosiver and its novel approach is another promising step for Canadian patients who are looking for new and effective options to manage these challenging symptoms."

In clinical studies, Rosiver Cream effects were seen as early as week two, with continuous improvement in patients with inflammatory lesions of rosacea.³  Furthermore, in a separate head-to-head study with metronidazole 0.75% cream – a current gold standard – Rosiver Cream was shown to be more efficacious from as early as three weeks onwards.⁴ While the mechanism of action of Rosiver Cream is unknown, ivermectin, the active ingredient in Rosiver Cream, has been reported to have both anti-inflammatory and antiparasitic activity.

Rosacea is progressive, meaning if symptoms are not treated, and triggers are not managed, they may worsen over time.  Rosacea is a chronic (long-term) condition, and while there is no cure, its symptoms can be reduced and managed. 

The approval of Rosiver Cream was based on two pivotal phase 3, multicentre, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies where Rosiver Cream met each of its co-primary efficacy endpoints.  The onset of treatment effect was observed as early as week two with continuous improvement.⁵  In long-term extensions to the 12-week studies, Rosiver Cream was also safe and well-tolerated for an additional 40 weeks (up to 52 weeks in total).⁶

"Galderma continues to demonstrate leadership in skin health and our commitment to innovation to better meet the needs of Canadian patients and clinicians," says Wendy Adams, General Manager of Galderma Canada. "Rosiver's approval is another great example of a novel treatment approach to meet the needs of patients managing the symptoms of rosacea."

For more information about Rosiver, see the product monograph at: http://galderma.ca/Portals/4/pdf/ROSIVER_product-monograph.pdf

About Galderma

Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime, while serving healthcare professionals around the world. The company has 34 wholly-owned affiliates with a worldwide network of distributors and more than 5,500 employees. Galderma's extensive product portfolio is available in 80 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis and steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.

Galderma is the operating company of Nestlé Skin Health, a global leader focused on enhancing the quality of life by delivering science-based solutions for the health of skin, hair and nails. Five state-of-the-art R&D centers and six manufacturing sites are dedicated to providing a wide range of innovative medical solutions, which meet the highest standards of safety and efficacy.

REFERENCES

^1	Rosiver™ Product Monograph, Galderma Canada Inc., April 22, 2015.
^2	Rosaceafacts.ca – Last accessed on June 17^th, 2015
^3	Rosiver™ Product Monograph, Galderma Canada Inc., April 22, 2015.
Data on file, Galderma Inc.
^4	Data on file, Galderma Inc.
^5	Rosiver™ Product Monograph, Galderma Canada Inc., April 22, 2015.
Data on file, Galderma Inc.
^6	Rosiver™ Product Monograph, Galderma Canada Inc., April 22, 2015.

SOURCE Galderma Canada

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