In Clinical Trials, BRYHALI Lotion Demonstrated Significant
Treatment Success Over Vehicle as Early as Week Two, Which
Continued Through Week 12 (Four Weeks Post
Treatment)1
New Corticosteroid Lotion Formulation with Safety Proven for
Up to Eight Weeks Duration of Use1
Company Plans to Launch BRYHALI Lotion in November 2018 Upon Final FDA approval
LAVAL, Quebec, Oct. 8, 2018 /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 that the U.S. Food and Drug
Administration (FDA) has provided tentative approval of the New
Drug Application for BRYHALI™ (halobetasol propionate)
Lotion, 0.01%, for the topical treatment of plaque psoriasis in
adult patients. BRYHALI Lotion is a new potent to superpotent
corticosteroid that contains 0.01 percent halobetasol propionate in
a novel vehicle lotion. Its safety has been established in clinical
trials with dosing for up to eight weeks with no increase in
epidermal atrophy. 1 The final FDA approval for BRYHALI
Lotion is pending the expiration of exclusivity for a related
product, which is expected in early November
2018. The company plans to launch BRYHALI
Lotion shortly thereafter, as scheduled, in November 2018.
"Our customers and their patients can benefit from this new
treatment option that is expected to provide the efficacy of a
high-potency steroid with tolerability and longer duration of use,"
said Bill Humphries, president,
Ortho Dermatologics. "Just as every psoriasis patient's journey is
different, so too are their treatment needs, which is why psoriasis
is a key therapeutic focus for our business. We look forward to
adding BRYHALI Lotion to our growing psoriasis portfolio."
Topical steroids are the most frequently used treatment for
psoriasis, but long-term use has been limited due to risks of
adverse events such as epidermal atrophy.2,3 Other local
adverse reactions from topical corticosteroids may include striae,
telangiectasias, hypopigmentation and contact dermatitis, and some
local adverse reactions may be irreversible. In clinical trials,
BRYHALI Lotion was applied once daily for eight weeks and shown to
be generally well-tolerated with no increase in epidermal
atrophy.1
"Topical steroids are a cornerstone of psoriasis treatment, but
the efficacy of a high-potency steroid often comes with an
increased risk of adverse events and a duration of use limited to
two to four weeks," said Lawrence J.
Green, M.D., associate clinical professor of Dermatology
at George Washington University
School of Medicine in Washington, D.C. "In clinical
trials BRYHALI Lotion has demonstrated good local tolerability for
up to eight weeks of treatment without sacrificing efficacy, making
it an important new treatment option for psoriasis
patients."1
BRYHALI Lotion Clinical Data
BRYHALI Lotion was
evaluated in two prospective, multicenter, randomized, double-blind
clinical trials to determine its safety and efficacy. The trials
were conducted in a total of 430 subjects who were 18 years of age
and older with moderate to severe plaque psoriasis. In Trials 1 and
2, 37 percent and 38 percent of patients, respectively, treated
with BRYHALI Lotion achieved treatment success (at least a
two-grade improvement from baseline in Investigator's Global
Assessment (IGA) and an IGA score equating to "clear" or "almost
clear"), compared to eight percent and 12 percent of patients
treated with vehicle. There was no increase in epidermal atrophy
over eight weeks of treatment.1
Data from both trials also showed that BRYHALI Lotion
demonstrated significant treatment success over vehicle as early as
week two (Study 1) and week four (Study 2), which continued through
12 weeks (four weeks post treatment).1
The most common adverse reactions occurring in ≥1 percent of
subjects treated with BRYHALI Lotion through week eight were upper
respiratory tract infection (2 percent), application site
dermatitis (1 percent) and hyperglycemia (1
percent).1
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
was observed and may occur with the potential for
glucocorticosteroid insufficiency during or after treatment with
BRYHALI Lotion.1
About Psoriasis
Psoriasis is an immune-mediated
disease that speeds up the life cycle of skin cells, causing them
to build up rapidly on the surface of the skin. The extra skin
cells form raised, red, scaly patches that are itchy and sometimes
painful.4 People with psoriasis are also reported to be
at increased risk of developing other serious clinical conditions
such as cardiovascular and other noncommunicable diseases and to
suffer substantial impairment of physical and psychological quality
of life.5 Plaque psoriasis is the most common type of
psoriasis.6
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 psoriasis, actinic keratosis, acne, atopic dermatitis and
other dermatoses. The Ortho Dermatologics portfolio includes
several leading acne, anti-fungal and anti-infective 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
- Green, LJ et al. Safety and Efficacy of a Once-Daily
Halobetasol Propionate 0.01% Lotion in the Treatment of
Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3
Randomized Controlled Trials. Journal of Drugs in Dermatology
17(10):2018. 602-609.
- National Psoriasis Foundation. Mild Psoriasis: Topical
Steroids. Retrieved from
https://www.psoriasis.org/about-psoriasis/treatments/topicals/steroids.
Accessed August 29, 2018.
- National Psoriasis Foundation. (September 2015). What you need to know about
steroids. Retrieved from
https://www.psoriasis.org/advance/what-you-need-to-know-about-steroids.
Accessed August 29, 2018.
- Mayo Clinic. (2017). Psoriasis. Retrieved from
https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840.
Accessed February 6, 2018.
- World Health Organization. (2016). Global Report on Psoriasis.
Retrieved from
http://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf;jsessionid=81463A56C4318AF777E56018DB67B563?sequence=1.
Accessed February 6, 2018.
- National Psoriasis Foundation. About Psoriasis. Retrieved from
https://www.psoriasis.org/about-psoriasis. Accessed March 30, 2018.
BRYHALI is a trademark of Ortho Dermatologics' affiliated
entities.
© 2018 All Rights Reserved.
BRY.0023.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.