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Shown to provide strong efficacy with good tolerability profile
Bausch Health, Canada which is part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) ("Bausch Health" or the "Company"), and its dermatology division, one of the largest prescription dermatology health care businesses in Canada, today announced that its new topical prescription treatment for acne vulgaris (common acne), ARAZLO TM (tazarotene) lotion, 0.045% ww, for patients 10 years of age and older 1 is now available across Canada .
ARAZLO is the first tazarotene 0.045% w/w lotion treatment formulated with PRISMATREX TM technology approved by Health Canada that delivers the benefits of tazarotene in a formulation with known hydrating and moisturizers to effectively treat acne with demonstrated efficacy and tolerability. 1
"We are very pleased that ARAZLO is now available for prescription by doctors across Canada as an important new option for them to help treat the approximately 5.6 million Canadians who are impacted by acne," 2 said Ginette Gagné, Interim President and General Manager, Bausch Health, Canada . "We are proud to be expanding our already large dermatology portfolio to better help meet Canadians' needs."
"The availability of ARAZLO provides an important new addition to how we can help our patients with acne by providing access to treatment by the powerful retinoid tazarotene in a lotion form that will help limit the dryness and irritation that has historically been a barrier to its long-term use by patients," 3 said Dr. Benjamin Barankin , MD, FRCPC, FAAD – Dermatologist, Toronto , Ontario. "It is a very useful and positive step forward for the treatment of acne."
ARAZLO is a lightweight non-greasy lotion that uses a polymeric emulsification system (PRISMATREX), which maintains the emulsion droplets size distribution stable across time and temperature. This system provides stable emulsions by anchoring its hydrophobic portions and forming an adsorbed gel layer around each oil droplet. 1
ARAZLO is the third new dermatology treatment from Bausch Health approved by Health Canada in just over 12 months. The other approvals were for BRYHALI™ (halobetasol propionate lotion 0.01% w/w), a high to super-high potency topical corticosteroid indicated for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis, and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis. 4
All three treatments – ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec , facility for Canada and the United States .
ARAZLO Comprehensive Clinical Data
The Health Canada approval for ARAZLO was based on data from two pivotal Phase 3 multicentre, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p<.001>
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada . It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population and causes emotional distress and can cause permanent scarring 2 or pigmentation changes. 5 Acne affects about 90 per cent of adolescents and about 25 per cent of teens will still have acne at age 25. 2
About ARAZLO
ARAZLO (tazarotene) lotion, 0.045% w/w is a prescription medicine used on the skin (topical) to treat people ten years of age and older with acne, which can include blackheads, whiteheads and other pimples, including inflammatory lesions, nodules and cysts. Safety and efficacy of ARAZLO in children below the age of 10 years has not been established.
About the Dermatology Portfolio of Bausch Health, Canada
Bausch Health, Canada has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada dermatology portfolio includes several leading acne, anti-fungal and corticosteroid-responsive dermatoses products.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at BauschHealth.ca .
REFERENCES
1. ARAZLO Lotion Product Monograph, July 7, 2021 .
2. Canadian Dermatology Association, Acne, https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040 , accessed July 15, 2021 .
3. "Targeted Topical Delivery of Retinoids in the Management of Acne Vulgaris: Current Formulations and Novel Delivery Systems." Pharmaceutics. Gemma Latter et al, October 2019 , https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6835300/ , accessed July 15, 2021 .
4. BRYHALI and DUOBRII Product Monographs, April 13, 2021 , and June 8, 2020 , respectively.
5. "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio , April 28 , 2020, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne , accessed July 15, 2021 .
SOURCE Bausch Health
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