Health Canada Approves ARAZLO Lotion, 0.045%, First Such Lotion Treatment For Acne Vulgaris

- August 4th, 2021

Shown to provide strong efficacy with good tolerability profile  Bausch Health, Canada, which is part of Bausch Health Companies Inc.  , and its dermatology division, one of the largest prescription dermatology health care businesses in Canada today announced that Health Canada has approved the Notice of Compliance  for ARAZLO TM  lotion, 0.045%, for the topical treatment of acne vulgaris  in …

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 Health Canada has approved the Notice of Compliance (NOC) for ARAZLO TM (tazarotene) lotion, 0.045%, for the topical treatment of acne vulgaris (common acne) in patients 10 years of age and older. 1

ARAZLO is the first tazarotene acne treatment available in a lotion formulated with PRISMATREX TM technology (a formulation with known hydrating and moisturizers, which may alleviate dryness of skin) 1 and has been shown to provide strong efficacy with a good tolerability profile. Retinoids like tazarotene are a core component of acne treatment.

“Today’s approval of ARAZLO showcases our continued commitment to expanding our acne portfolio to help the approximately 5.6 million Canadians who are impacted by this prevalent skin condition,” 2 said Ginette Gagné, Interim President and General Manager, Bausch Health , Canada. “ARAZLO will provide diverse patient populations as well as physicians with the efficacy expected of tazarotene in a new formulation that helps reduce the dryness and irritation historically associated with tazarotene use, which can cause many acne patients to discontinue treatment.” 3

“Tazarotene is a powerful retinoid that has been shown to be effective in treating inflammatory and non-inflammatory acne lesions.  But, it can be challenging for many patients to remain on treatment, because of how it dries out the skin and other irritation challenges,” said Dr. Monica Li , Dermatologist, MD, FRCPC, FAAD, Vancouver , British Columbia. ”ARAZLO provides a potential solution by making tazarotene available in a honeycomb mesh delivery technology formulation that can provide hydrating and moisturizing effects simultaneously. I’m excited to welcome a new acne treatment option for those Canadians affected by acne who can possibly benefit from effective tazarotene treatment that can be better tolerated.”

ARAZLO is a lightweight non-greasy lotion that uses a polymeric emulsification system (PRISMATREX TM ), 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. The product’s target pH (5.0 – 6.0) is controlled by the amount of polymer and base (sodium hydroxide) present in the formulation. This pH range is consistent with the pH tolerated by the skin without inducing irritation.

ARAZLO is the third new dermatology treatment from Bausch Health, Canada approved by Health Canada in just over 12 months, adding to the company’s leading portfolio in this important treatment area. 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 multicenter, 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 arazlo was also shown to be generally well-tolerated in the clinical study population.>

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

What is ARAZLO?
ARAZLO (tazarotene) lotion, 0.045% 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.

It is not known if ARAZLO is safe and effective in children below the age of ten years.

About Bausch Health Dermatology
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 portfolio includes several leading acne, anti-fungal and corticosteroid-responsive dermatoses products.

About Bausch Health
Bausch Health Companies Inc. (NYSE/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 8, 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, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne , accessed July 15, 2021.

SOURCE Bausch Health

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