Health Canada Issues Notice of Compliance for Bausch Health's DUOBRII™
TOPICAL COMBINATION IMPROVING THE SIGNS AND SYMPTOMS OF PLAQUE PSORIASIS IN ADULT PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS FORMULATED WITH PROPRIETARY PRISMATREX™ TECHNOLOGY i
LAVAL, QC, June 11, 2020 /CNW Telbec/ - Bausch Health, Canada, which is part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") has announced that Health Canada has approved the use of DUOBRIITM (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) lotion, a topical prescription medicine indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.i
A chronic inflammatory condition affecting the regeneration of skin cells, psoriasis affects its patients not just physically, but also emotionallyii. Studies suggest that about one million Canadians are impacted by this skin disease, with 90% of those affected suffering from plaque psoriasis.ii
DUOBRII is the first and only complementary retinoid-steroid combination of two ingredients – halobetasol propionate, which helps with the inflammation associated with psoriasis; and tazarotene helps with the normal growth of skin cells and by reducing inflammation.i DUOBRII is formulated with a unique and proprietary technology called Prismatrex, a polymeric emulsification system which provides a stable condition of the product where emulsion droplets retain their distribution across time and temperature.iii
"With Health Canada's approval of DUOBRII, patients suffering from plaque psoriasis will soon have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene with established safety profiles, into a single lotion offering the complementary benefits of a retinoid with a steroid for the first line treatment of moderate to severe psoriasis," said Richard Lajoie, President and General Manager, Bausch Health, Canada. "Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms. Now, with DUOBRII, Canadian health care professionals and their patients have a new topical treatment option that can help achieve those long-term goals. We remain committed to bringing forward new medicines, like DUOBRII to meet the varying treatment needs of patients with psoriasis."
Psoriasis is a difficult condition to treat," said Dr. Neil H. Shear, MD, FRCPC, Professor and Head of Dermatology, Sunnybrook Health Sciences Centre. "Because psoriasis typically appears on visible parts of the body, it has a significant effect on how my patients feel and interact with others. Without question, achieving clear skin is the goal of patients and physicians alike. DUOBRII, which combines a corticosteroid and a retinoid, is the first new topical treatment option for psoriasis in many years, with encouraging results that can be seen in as early as two weeks. As well, it is the only topical treatment that provides extended clearance post-treatment."
Clinical trials and studies demonstrated that DUOBRII was statistically significantly more effective than Vehicle Lotion in achieving treatment success in the IGA at Week 8, defined as at least a 2-grade improvement from Baseline and a score of Clear or Almost Clear in the studies.i According to Dr. Shear, while other products containing steroids used for treating psoriasis have a limit to the length of time for their usage, DUOBRII has no treatment duration limitation. "Patients can use it until their skin is clear and can re-initiate treatment as needed."
"Having access to a new, first-line topical treatment is an important advance for patients with plaque psoriasis," said Rachael Manion of the Canadian Association of Psoriasis Patients (CAPP). "The psoriasis community welcomes the addition of this new once-daily topical treatment optioniv to the psoriasis treatment toolkit, especially in light of reduced treatment options for some people living with psoriasis during the COVID-19 pandemic."
It is expected that DUOBRII will be commercially available in Canada in late summer 2020.
DUOBRII is manufactured for US and Canadian patients at Bausch Health's Laval, Quebec manufacturing facility.
About Bausch Health Companies Inc.
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.
In Canada, the Company's prescription product portfolio is focused on eye health, dermatology and cardio-metabolic conditions. More information can be found on the Company's website at bauschhealth.ca.
|i DUOBRIITM Product Monograph. Bausch Health, Canada Inc. June 8, 2020 |
iii Data in Health Canada NDS submission
iv Comment is in reference to inconsistent availability to phototherapy during COVID-19 pandemic. Canadian Skin Patient Alliance website: https://canadianskin.ca/education/covid-19#i-am-receiving-phototherapy-for-my-skin-disease-are-dermatologists-continuing-to-offer-these-treatments-in-their-clinics
SOURCE Bausch Health