Health Canada Approves (Pr)CABTREO(TM) (clindamycin phosphate, adapalene and benzoyl peroxide) Triple-Combination Topical Treatment for Acne Vulgaris in Patients 12 Years of Age and Older
Health Canada has approved CABTREO, a new triple-combination topical treatment for acne vulgaris in patients 12 years and older. Developed by Bausch Health (NYSE:BHC, TSX:BHC), CABTREO is the first and only triple-combination topical acne treatment approved in Canada, combining an antibiotic (clindamycin phosphate), a retinoid (adapalene), and an antibacterial agent (benzoyl peroxide). The once-daily gel has shown significant success in reducing both inflammatory and non-inflammatory acne lesions. CABTREO will be available in Canadian pharmacies in Q4 2024, offering a new option for millions of Canadians affected by acne.
Salute Canada ha approvato CABTREO, un nuovo trattamento topico a tripla combinazione per l'acne vulgaris in pazienti di età pari o superiore a 12 anni. Sviluppato da Bausch Health (NYSE:BHC, TSX:BHC), CABTREO è il primo e unico trattamento topico per l'acne a tripla combinazione approvato in Canada, che combina un antibiotico (fosfato di clindamicina), un retinoide (adapalene) e un agente antibatterico (perossido di benzoile). Il gel a somministrazione giornaliera ha mostrato un notevole successo nella riduzione sia delle lesioni acneiche infiammatorie che non infiammatorie. CABTREO sarà disponibile nelle farmacie canadesi nel quarto trimestre del 2024, offrendo una nuova opzione per milioni di canadesi colpiti dall'acne.
Salud Canadá ha aprobado CABTREO, un nuevo tratamiento tópico de combinación triple para el acné vulgar en pacientes de 12 años en adelante. Desarrollado por Bausch Health (NYSE:BHC, TSX:BHC), CABTREO es el primer y único tratamiento tópico para el acné de combinación triple aprobado en Canadá, combinando un antibiótico (fosfato de clindamicina), un retinoide (adapaleno) y un agente antibacterial (peróxido de benzoilo). El gel de aplicación diaria ha demostrado un éxito significativo en la reducción tanto de las lesiones acneicas inflamatorias como no inflamatorias. CABTREO estará disponible en las farmacias canadienses en el cuarto trimestre de 2024, ofreciendo una nueva opción para millones de canadienses afectados por el acné.
캐나다 보건부는 12세 이상의 환자를 위한 여드름 vulgaris의 새로운 삼중 조합 국소 치료제인 CABTREO를 승인했습니다. Bausch Health (NYSE:BHC, TSX:BHC)에서 개발한 CABTREO는 캐나다에서 승인된 첫 번째이자 유일한 삼중 조합 국소 여드름 치료제로, 항생제(클린다마이신 인산염), 레티노이드(아다팔렌) 및 항균제(벤조일 과산화물)를 결합합니다. 하루에 한 번 사용하는 이 젤은 염증성 및 비염증성 여드름 병변 모두를 줄이는 데 상당한 성공을 보여주었습니다. CABTREO는 2024년 4분기부터 캐나다 약국에서 제공될 예정으로, 여드름에 영향을 받는 수백만 캐나다인에게 새로운 선택지를 제공합니다.
Santé Canada a approuvé CABTREO, un nouveau traitement topique à triple combinaison pour l'acné vulgaris chez les patients âgés de 12 ans et plus. Développé par Bausch Health (NYSE:BHC, TSX:BHC), CABTREO est le premier et unique traitement topique pour l'acné à triple combinaison approuvé au Canada, combinant un antibiotique (phosphate de clindamycine), un rétinoïde (adapalène) et un agent antibactérien (peroxyde de benzoyle). Le gel à utilisation quotidienne a montré un succès significatif dans la réduction des lésions acnéiques inflammatoires et non inflammatoires. CABTREO sera disponible dans les pharmacies canadiennes au quatrième trimestre 2024, offrant une nouvelle option pour des millions de Canadiens touchés par l'acné.
Health Canada hat CABTREO genehmigt, eine neue topische Behandlung mit einer dreifachen Kombination für Akne vulgaris bei Patienten ab 12 Jahren. Entwickelt von Bausch Health (NYSE:BHC, TSX:BHC), ist CABTREO die erste und einzige topische Aknebehandlung mit dreifacher Kombination, die in Kanada genehmigt wurde. Sie kombiniert ein Antibiotikum (Clindamycinphosphat), ein Retinoid (Adapalen) und ein antibakterielles Mittel (Benzoylperoxid). Das einmal täglich anzuwendende Gel hat signifikante Erfolge bei der Reduzierung sowohl entzündlicher als auch nicht entzündlicher Akne-Läsionen gezeigt. CABTREO wird im vierten Quartal 2024 in kanadischen Apotheken erhältlich sein und bietet eine neue Option für Millionen von Kanadiern, die von Akne betroffen sind.
- First and only triple-combination topical acne treatment approved in Canada
- Demonstrated significant success in reducing acne lesions
- Convenient once-daily dosing
- Expanding product portfolio in dermatology treatments
- None.
The approval of CABTREO marks a significant advancement in acne treatment. As the first triple-combination topical treatment approved in Canada, it combines clindamycin phosphate (antibiotic), adapalene (retinoid) and benzoyl peroxide (antibacterial agent). This unique formulation targets multiple aspects of acne pathogenesis, potentially offering superior efficacy compared to single or dual-action treatments.
Clinical studies have shown CABTREO's effectiveness in reducing both inflammatory and non-inflammatory lesions, addressing the full spectrum of acne manifestations. The once-daily application could improve patient adherence, a important factor in acne management. However, long-term safety data and potential antibiotic resistance concerns will need monitoring.
This approval represents a potential revenue boost for Bausch Health (NYSE:BHC)(TSX:BHC). The acne treatment market in Canada is substantial, with millions affected annually. CABTREO's unique triple-combination formula could provide a competitive edge, potentially capturing a significant market share.
Investors should note the Q4 2024 launch timeline, which could impact short-term financials. The product's success will depend on factors like pricing strategy, marketing efforts and physician adoption rates. While this approval is positive, it's important to consider it within the context of Bausch Health's overall product portfolio and financial health. The company's ability to effectively commercialize CABTREO will be key to translating this regulatory win into tangible financial benefits.
CABTREO's approval could significantly impact the Canadian acne treatment landscape. With its triple-action mechanism, it addresses a gap in the market for more comprehensive topical treatments. The once-daily application aligns with consumer preferences for convenience, potentially driving adoption.
However, market success will depend on several factors. Pricing will be crucial, especially in comparison to existing combination treatments. Additionally, education of both healthcare providers and patients about the benefits of this triple-combination approach will be vital. The product's performance in real-world settings, especially regarding side effects and long-term efficacy, will influence its market position. Competitors' responses, such as potential price adjustments or increased marketing of existing products, should also be monitored for their impact on CABTREO's market penetration.
LAVAL, QC / ACCESSWIRE / September 11, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the approval by Health Canada of PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel
CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action - an antibiotic, a retinoid and an antibacterial agent - to provide a safe and effective treatment.1
"The approval of CABTREO shows the continuing commitment of Bausch Health to bring innovative dermatology treatments to Canadians," said Amy Cairns, Vice-President, Commercial and General Manager, Canada, Bausch Health. "We are proud to offer this first triple-combination topical acne treatment to millions of Canadians who suffer from acne each year."
CABTREO is a topical gel that is administered by patients once daily to affected areas of their skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene, and the oxidizing agent benzoyl peroxide which has a broad-spectrum anti-bacterial activity.1
"The unique triple combination provided by CABTREO has shown significant treatment success in studies, reducing both the inflammatory and non-inflammatory skin lesions we associate with acne," said Dr. Jerry Tan, MD, FRCPC, a dermatologist in Windsor, Ontario, and Adjunct Professor at Western University in London, Ontario. "The convenient once-daily dosing of CABTREO will also be important to many patients."
CABTREO will be made available through pharmacies across Canada in the fourth quarter this year.
"People with acne are always hopeful and excited when there is a new approved treatment in Canada that might help them," said Sue Sherlock, Executive Director of the Acne and Rosacea Society of Canada. "Acne can significantly impact the emotional and social well-being of sufferers so having effective treatments is important to them."
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, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3
CABTREO Clinical Data and Safety Information
CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately
The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide and others), patients with a history of regional enteritis (Crohn's disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1
Health Canada has not authorized CABTREO for pediatric use under the age of 12 years.CABTREO is for topical use only and is not for oral, ophthalmic use or intravaginal use.1
About Dermatology at 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, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products.
CABTREO is the fourth new dermatology treatment from Bausch Health, Canada approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene) lotion,
All four treatments - CABTREO, ARAZLO, BRYHALI and DUOBRII - are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
REFERENCES
1 Bausch Health, Canada Inc., CABTREO Product Monograph, https://pdf.hres.ca/dpd_pm/00076715.PDF.
2 Canadian Dermatology Association, Acne, Quick Facts, https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%
3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024.
4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.
Investor Contacts:
Garen Sarafian
ir@bauschhealth.com
(877) 281-6642 (toll free)
Media Contact:
Katie Savastano
corporate.communications@bauschhealth.com
(908) 569-3692
SOURCE: Bausch Health Companies Inc.
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FAQ
What is CABTREO and what has Health Canada approved it for?
What are the active ingredients in CABTREO (BHC)?
When will CABTREO be available in Canadian pharmacies?
How is CABTREO administered for acne treatment?
