LAVAL, Quebec, Oct. 30, 2018 /CNW/ -- 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 U.S. launch of
ALTRENOTM (tretinoin) Lotion, 0.05% for the topical
treatment of acne vulgaris in patients 9 years of age and older.
ALTRENO Lotion is the first and only tretinoin available in a
lotion for acne. ALTRENO Lotion has been shown to be effective and
generally well-tolerated, and is provided in a formulation with
known moisturizers hyaluronic acid, glycerin and
collagen.1
"We are proud to make ALTRENO Lotion available as a new option
for acne patients, providing the trusted efficacy of a tretinoin,
but in a lotion formulation that is generally well-tolerated and
helps hydrate and moisturize the skin," said Bill Humphries, president, Ortho Dermatologics.
"Millions of Americans are affected by acne, and the launch of
ALTRENO Lotion underscores our commitment to expanding the
treatment possibilities for this community."
The U.S. Food and Drug Administration approved ALTRENO Lotion on
Aug. 24, 2018, based on data from two
identical multicenter, randomized, double-blind, vehicle-controlled
Phase 3 studies that demonstrated ALTRENO Lotion resulted in
statistically significant reductions in both inflammatory and
non-inflammatory lesions compared to vehicle. In the studies,
ALTRENO Lotion was shown to have significantly greater efficacy
compared to vehicle in achieving treatment success, which was
defined as at least a two-grade improvement from baseline and clear
to almost clear in acne severity by Evaluator Global Severity Score
(EGSS). The most common adverse reactions, occurring in >1% of
subjects and greater than vehicle, were dryness, pain, erythema,
irritation and exfoliation.
"Many acne patients struggle using acne medications because they
can cause irritation to the skin," said Joshua Zeichner, M.D., director, Cosmetic and
Clinical Research in Dermatology, The Mount Sinai Hospital,
New York City. "ALTRENO Lotion has
demonstrated the efficacy of a tretinoin with a proven tolerability
profile. Greater tolerability may help improve adherence to skin
care regimens, which may ultimately lead to better patient
outcomes."
About Acne Vulgaris
Acne is the most common skin
problem in the United States that
occurs when hair follicles become plugged with oil and skin cells,
often causing whiteheads, blackheads or pimples and appearing on
the face, forehead, chest, upper back and shoulders. Up to 50
million Americans have acne.2 Depending on its severity,
acne can cause emotional distress and scar the
skin.3
About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription dermatology
businesses dedicated to helping patients in the treatment of a
range of therapeutic areas including actinic keratosis, acne,
atopic dermatitis, cold sores, athlete's foot, nail fungus and
other dermatoses. The Ortho Dermatologics portfolio includes
several leading acne, antifungal and corticosteroid-responsive
dermatoses products. 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.
IMPORTANT SAFETY INFORMATION FOR ALTRENO™ (TRETINOIN 0.05%)
LOTION
WHAT IS ALTRENO™?
ALTRENO (tretinoin) lotion, 0.05% is
a prescription medicine used on the skin (topical) to treat people
with acne (blackheads, whiteheads, and other pimples).
IMPORTANT SAFETY INFORMATION
It is not known if
ALTRENO is safe and effective in children under 9 years of age.
ALTRENO is for use on the skin only. Do not use it in your eyes,
mouth, or vagina.
What should I tell my healthcare provider before using
ALTRENO?
Before you use ALTRENO, tell your healthcare
provider about all of your medical conditions, including if
you:
- are allergic to fish. ALTRENO contains fish proteins. Tell your
healthcare provider if you get hives or itching during treatment
with ALTRENO.
- have eczema or any other skin problems.
- have a sunburn.
- are pregnant or plan to become pregnant. It is not known if
ALTRENO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
ALTRENO passes into your breast milk.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Certain medicines,
vitamins, or supplements may make your skin more sensitive to
sunlight. Tell your healthcare provider about any
cosmetics you use, including moisturizers, creams, lotions, or
products that can dry out your skin.
What should I avoid while using ALTRENO?
- You should avoid sunlamps, tanning beds, and ultraviolet light
during treatment with ALTRENO.
- Minimize exposure to sunlight. If you have to be in the
sunlight or are sensitive to sunlight, use a sunscreen with an SPF
of 15 or more and wear protective clothing and a wide-brimmed hat
to cover the treated areas.
What are the possible side effects of ALTRENO?
ALTRENO may cause serious side effects, including:
Skin Irritation: ALTRENO may cause irritation,
including skin dryness, pain, redness, excessive flaking or
peeling. If you develop these symptoms, your healthcare provider
may tell you to stop using ALTRENO for a while, decrease how often
you use it, or stop it altogether. Avoid applying ALTRENO to skin
that is affected by eczema or sunburned.
- These are not all the possible side effects of ALTRENO.
- Call your healthcare provider for medical advice about side
effects.
You are encouraged to report negative side effects of
prescription drugs. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please click here for full Prescribing Information.
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,"
"will," "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, risks and uncertainties discussed in the
Company's most recent annual or quarterly report and detailed from
time to time in the Company's other filings with the Securities and
Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. In addition,
certain material factors and assumptions have been applied in
making these forward-looking statements, including that the risks
and uncertainties outlined above will not cause actual results or
events to differ materially from those described in these
forward-looking statements. The Company believes that the material
factors and assumptions reflected in these forward-looking
statements are reasonable, but 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
1. ALTRENOTM [prescribing
information]. Bridgewater, NJ:
Ortho Dermatologics.
2. American Academy of Dermatology. (2018).
Skin conditions by the numbers. Retrieved from
https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers.
Accessed August 6, 2018.
3. Mayo Clinic. (2018). Acne. Retrieved from
https://www.mayoclinic.org/diseases-conditions/acne/symptoms-causes/syc-20368047.
Accessed July 24, 2018.
ALTRENO is a trademark of Ortho Dermatologics' affiliated
entities.
© 2018 All Rights
Reserved.
ALT.0077.USA.18
Investor
Contact: Media
Contact:
Arthur
Shannon Lainie
Keller
arthur.shannon@bauschhealth.com
lainie.keller@bauschhealth.com
(514)
856-3855 (908)
927-0617
(877) 281-6642 (toll
free)
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SOURCE Bausch Health Companies Inc.