ALTRENO Lotion Provides Statistically Significant Greater
Efficacy Over Vehicle with a Favorable Safety and Tolerability
Profile in Two Pivotal Clinical Trials1
LAVAL, Quebec, Oct. 11, 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 that the Journal of Drugs in
Dermatology has published results of two identical Phase 3,
multicenter, randomized, double-blind, vehicle-controlled, parallel
group studies examining the efficacy and safety of
ALTRENOTM (tretinoin) Lotion, 0.05%, the first
formulation of tretinoin, a retinoid, in a lotion indicated for the
topical treatment of acne vulgaris in patients 9 years of age and
older.1 The U.S. Food and Drug Administration approved
the New Drug Application for ALTRENO Lotion on Aug. 24, 2018.
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 in a global severity by Evaluator Global Severity Score
(EGSS) and 'clear' or 'almost clear' skin. By week 12, 17.7 percent
of ALTRENO Lotion patients had achieved treatment success, compared
to 9.3 percent of patients receiving vehicle. ALTRENO Lotion also
demonstrated statistically significant reductions in both
inflammatory and noninflammatory lesion counts (both
P<.001) at week 12 compared to vehicle (52.1 percent
versus 41.0 percent for inflammatory lesion counts and 46.1 percent
versus 29.9 percent in noninflammatory lesion counts). The most
common adverse reactions were application site pain (3.1 percent),
dryness (3.7 percent) and erythema (1.4 percent). ALTRENO Lotion
was found to be generally well-tolerated among treatment
groups.1
"Extensive clinical data have shown that topical retinoids are
highly effective in acne and are recommended as the cornerstone of
topical therapy; however, retinoids are perceived to have limited
efficacy in inflammatory acne and that tolerability issues are
barriers to their use. The results from the two Phase 3 clinical
trials demonstrated that ALTRENO can provide physicians and their
patients a new treatment option that significantly reduces
inflammatory and noninflammatory acne lesions along with a
favorable tolerability profile," said Sabrina Fabi, M.D., a dermatologist and
dermatologic cosmetic surgeon from Cosmetic Laser Dermatology,
San Diego, and assistant clinical
professor, University of California, San
Diego.
Patient satisfaction was also shown to be significantly greater
with ALTRENO Lotion compared to vehicle, increasing from baseline
to week 12 by 53 percent compared to 43 percent with vehicle
(P<.001), and with nine out of 10 patients reporting
satisfaction with their treatment. Patient satisfaction was
measured using the acne-specific quality of life (Acne-QoL)
questionnaire. The 19-item Acne-QoL is a validated psychometric
instrument designed for use in clinical trials.1
"Helping to make a difference in the lives of people living with
skin conditions, such as acne, is the driving force behind our work
at Ortho Dermatologics," said Bill
Humphries, president, Ortho Dermatologics. "We believe these
new data further demonstrate the value that ALTRENO Lotion provides
patients with acne vulgaris, and we look forward to bringing the
product to market by the end of the month."
About the Phase 3 Studies
The study design consisted
of two identical multicenter, randomized, double-blind, vehicle
controlled, parallel-group Phase 3 studies to determine the
efficacy, safety and tolerability of ALTRENO Lotion, compared to
vehicle, among 1,640 patients, 9-58 years of age, with an Evaluator
Global Severity Score (EGSS) score of three (moderate) or four
(severe).1
Patients were randomized 1:1 to receive ALTRENO Lotion or
vehicle once-daily for 12 weeks, with assessments carried out at
four, eight and 12 weeks of treatment. The primary efficacy
endpoint was the absolute change from baseline to week 12 in mean
inflammatory and noninflammatory lesion counts, and the proportion
of patients who were clear to almost clear achieved at least a
two-grade reduction from baseline to week 12 in EGSS. Secondary
efficacy endpoints included mean percent change from baseline to
week 12 in inflammatory and noninflammatory lesion counts and the
proportion of patients who achieved at least a two-grade reduction
from baseline.1
Additional assessments included a patient satisfaction score
(PSS) assessment, a validated acne-specific quality of life
(Acne-QoL) questionnaire and an assessment of degree of
shininess/oiliness of facial skin and its range of bothersomeness.
Safety adverse events, which were summarized by treatment group,
severity, and relationship to study medication, were evaluated
throughout.1
IMPORTANT SAFETY INFORMATION FOR ALTRENO™ (TRETINOIN), 0.05%
LOTION
What is Altreno™?
ALTRENO 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 skin only. Do not use it in your eyes, mouth,
or vagina
Before you use ALTRENO, tell your healthcare provider about
all 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.
Also, 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 a 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 have 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 skin.
- These are not all the possible side effects of ALTRENO.
- Call your healthcare provider for medical advice about side
effects.
You may report side effects to the FDA at
1-800-FDA-1088.
Please click here for full Prescribing Information.
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.
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
- Tyring, Stephen K. et al. Novel Tretinoin 0.05% Lotion for the
Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris;
Assessment of Efficacy and Safety in Patients Aged 9 Years and
Older. Journal of Drugs in Dermatology. 17(10):2018. 602-609.
- 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.
- 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.0080.USA.18
Investor
Contact:
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Media
Contact:
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Shannon
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(908)
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SOURCE Bausch Health Companies Inc.