ARAZLO™ (tazarotene) Lotion, 0.045% is
Indicated for the Topical Treatment of Acne Vulgaris in Patients
Nine Years of Age and Older
LAVAL, QC, June 23, 2020 /CNW/ -- Bausch Health Companies
Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho
Dermatologics, one of the largest prescription dermatology health
care businesses in the world, today announced that
ARAZLO™ (tazarotene) Lotion, 0.045%, is available
commercially to health care professionals in the United States this week. Approved by the
U.S. Food and Drug Administration (FDA) in December 2019, ARAZLO is the first tazarotene
acne treatment available in lotion formulation.
"Retinoids like tazarotene are highly effective in treating acne
and considered a cornerstone of acne treatment, but often are
perceived to be associated with skin irritation.1
Clinical studies have demonstrated that ARAZLO's proprietary
formulation provides the proven efficacy of a retinoid in a lotion
that is more tolerable to patients than a higher concentration
tazarotene," said Bill Humphries,
president, Ortho Dermatologics. "Ortho Dermatologics remains
committed to bringing forward new treatment options like ARAZLO to
help the millions of Americans who suffer from acne."
In a Phase 2, head-to-head study, ARAZLO and Tazorac
(tazarotene) Cream 0.1% showed similar treatment success rates and
similar reductions in both inflammatory and non-inflammatory
lesions over 12 weeks and ARAZLO was associated with about half the
number of adverse events and fewer treatment-related adverse
events.1
"The novel lotion formulation of ARAZLO has been shown to be
generally well-tolerated, allowing more patients with multiple
types of acne to take advantage of its efficacy1," said
Emil Tanghetti, M.D., lead ARAZLO
study investigator and founder of the Center for Dermatology and
Laser Surgery, Sacramento, Calif.
"I am excited to offer ARAZLO to my patients and anticipate they
will be pleased with their results."
ARAZLO is priced comparable to many other branded acne products
indicated to treat moderate-to-severe acne vulgaris. For most
eligible patients whose commercial insurance covers the product,
they should have no co-pay (or $0
co-pay) when utilizing the ARAZLO coupon at participating
pharmacies. Most other eligible, commercially insured patients will
have a co-pay of as little as $65
through our access program.
ARAZLO Comprehensive Clinical Data
The FDA approval
for ARAZLO was based on data from two 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.2
In a Phase 2, head-to-head study, ARAZLO and Tazorac
(tazarotene) Cream 0.1% showed similar treatment success rates and
similar reductions in both inflammatory and non-inflammatory
lesions over 12 weeks.2 While there were no significant
differences in patient satisfaction or quality of life and both
were well-tolerated, Tazorac was associated with nearly double the
number of treatment-related adverse events (5.6 percent with
Tazorac versus 2.9 percent with ARAZLO), the study
reported.2
About Acne Vulgaris
Acne is the most common skin
problem in the United States,
which occurs when hair follicles become plugged with oil and skin
cells, often causing whiteheads, blackheads or pimples to appear on
the face, forehead, chest, upper back and shoulders.3 Up
to 50 million Americans have acne.4 Depending on its
severity, acne can cause emotional distress and scar the
skin.3
Important Safety Information for ARAZLOTM (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.
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. More
information can be found at www.bauschhealth.com.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words
"anticipates," "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.
References
- Tanghetti EA, Kircik LH, Green LJ, et. Al. A Phase 2
multicenter, double-blind, randomized, vehicle- controlled clinical
study to compare the safety and efficacy of a novel tazarotene
0.045% lotion and tazarotene 0.1% cream in the treatment of
moderate-to-severe acne vulgaris. J Drugs Dermatol.
2019;18(6):542-548.
- ARAZLO Lotion [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.
- Mayo Clinic. (2020). Acne. Retrieved from
https://www.mayoclinic.org/diseases-conditions/acne/symptoms-causes/syc-20368047.
Accessed Apr. 30, 2020.
- American Academy of Dermatology. (2019). Skin conditions by the
numbers. Retrieved from
https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers.
Accessed June 4, 2020.
ARAZLO is a trademark of Ortho Dermatologics' affiliated
entities.
Any other product/brand names are trademarks of
the respective owners.
© 2020 Ortho Dermatologics'
affiliated entities.
ARZ.0078.USA.20
Investor
Contact:
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Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-1198
|
(877) 281-6642 (toll
free)
|
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SOURCE Bausch Health Companies Inc.