Eight Poster Presentations Include New Analyses of ARAZLO®,DUOBRII® and SILIQ®
LAVAL, QC, Oct. 19, 2021 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of eight posters during the Fall Clinical Dermatology Conference, which takes place Oct. 21-24, 2021. The presentations will feature new efficacy and safety analyses of ARAZLO® (tazarotene) Lotion, 0.045%, long-term outcomes of DUOBRII® (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%, quality of life improvement with SILIQ® (brodalumab) injection 210 mg/1.5 ml and new onychomycosis treatment recommendations. Please see below for warning about suicidal ideation and behavior with SILIQ. The company will also host two educational events on ARAZLO® and DUOBRII®.
The complete list of poster presentations that will include Ortho Dermatologics products, as well as the list of featured events is as follows:
ARAZLO® (tazarotene) Lotion, 0.045%
"Efficacy and Safety of Tazarotene 0.045% Lotion in White Adults with Moderate-to-Severe Acne." Del Rosso et al.
"Tazarotene 0.045% Lotion for Acne: Formulation, Application Characteristics, and Clinical Efficacy and Safety." Draelos et al.
"Improvements in Acne and Skin Oiliness with Tazarotene 0.045% Lotion in Acne Patients with Oily Skin." Tanghetti et al.
DUOBRII® (halobetasol propionate and tazarotene) Lotion 0.01%/0.045%
"Long-term Outcomes of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion Stratified by Baseline Signs and Symptoms of Psoriasis." Kircik et al.
"Long-Term Safety and Efficacy of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion in Patients With Clinically Meaningful Improvement in Plaque Psoriasis." Alexis et al.
SILIQ® (brodalumab) injection 210 mg/1.5 ml
"Efficacy of Brodalumab vs Ustekinumab by Prior TNFα Inhibitor Exposure: Post hoc Analysis of Two Phase 3 Psoriasis Studies." Menter et al.
"Retreatment With Brodalumab Results in Skin Clearance and Improvements in Quality of Life in Patients With Psoriasis After Treatment Interruption." Armstrong et al.
Onychomycosis Treatment Recommendations
"Therapeutic Recommendations for the Treatment of Toenail Onychomycosis in the US." Lipner et al.
Thursday, Oct. 21 "ARAZLO® (tazarotene) Lotion, 0.045%, Changing the Paradigm of Retinoid Therapy" 11:35 a.m. to 12:05 p.m. ET at the Wynn Las Vegas in the Hermitage room (3131 S Las Vegas Blvd, Las Vegas) James Del Rosso, D.O., will discuss the clinical data behind ARAZLO®, the first and only tazarotene lotion that offers an improved tolerability profile in a patented polymeric mesh technology, and the benefits it offers for appropriate acne patients.
Saturday, Oct. 23 "Changing Impressions of Topical Therapy: DUOBRII® Lotion" 6:30 to 7:00 a.m. ET at the Wynn Las Vegas in the Castillon room (3131 S Las Vegas Blvd, Las Vegas) During the session, Ted Lain, M.D., will share how DUOBRII® uniquely treats plaque psoriasis with the synergy of a strong anti-inflammatory agent to clear plaques and a vitamin A derivative that helps extend the clearing process.
What is SILIQ? SILIQ (brodalumab) injection is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
What is the most important information I should know about SILIQ?
Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening depression, anxiety, or mood problems; thoughts of suicide, dying, or hurting yourself; attempt to commit suicide, or acting on dangerous impulses; other unusual changes in your behavior or mood.
Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.
This is not all the Important Safety Information you need to know about SILIQ. Please click here for full Prescribing Information for SILIQ, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.
Important Safety Information for ARAZLO® (tazarotene) Lotion, 0.045%
What is ARAZLO? ARAZLO® (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.
It is not known if ARAZLO is safe and effective in children under 9 years of age.
Important Safety Information ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.
What is the most important information I should know about ARAZLO?
ARAZLO may cause birth defects if used during pregnancy.
You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
Use effective birth control during treatment.
Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.
Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:
have eczema or any other skin problems.
are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure.
Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.
What should I avoid while using ARAZLO?
You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
Minimize exposure to sunlight; you could get severe sunburn.
If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.
Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.
ARAZLO may cause side effects, including:
Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.
These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Click here for full Prescribing Information, including Patient Information.
DUOBRII® Lotion Indication and Important Safety Information
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.
DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.
DUOBRII Lotion may cause birth defects if used during pregnancy.
Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.
DUOBRII may cause side effects, including:
If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
Cushing's syndrome, a condition from too much exposure to the hormone cortisol
High blood sugar (hyperglycemia)
The most common side effects of DUOBRII Lotion include redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This is not all of the Important Safety Information you need to know about DUOBRII; please click here for full Prescribing Information, including Patient Information.
About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.
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. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements 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. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health's most recent annual report on Form 10-K 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. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). 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. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
ARAZLO, DUOBRII and SILIQ are trademarks of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities.