Two Pivotal Trials Demonstrate the Efficacy of
Investigational Drug BRYHALI Lotion Over Vehicle at Eight Weeks of
Treatment, with Favorable Tolerability Profile1
LAVAL, Quebec, Oct. 2, 2018 /CNW/ -- Ortho Dermatologics, one of
the largest prescription dermatology health care businesses, and
its parent company, Bausch Health Companies Inc. (NYSE/TSX: BHC),
today announced that the Journal of Drugs in Dermatology has
published results of two Phase 3 randomized controlled trials
(Studies 1 and 2) examining the safety and efficacy of
BRYHALITM* (halobetasol propionate) Lotion, 0.01%, an
investigational potent to superpotent** corticosteroid,
in the treatment of moderate-to-severe plaque
psoriasis.1 BRYHALI Lotion has a Prescription Drug User
Fee Act (PDUFA) action date of October 5,
2018.
In the studies, BRYHALI Lotion was consistently more effective
than vehicle in achieving treatment success, which was defined as
at least a two-grade improvement from baseline in an Investigator
Global Assessment (IGA) score, and 'clear' or 'almost clear' skin.
By week eight, 36.5 percent (Study 1) and 38.4 percent (Study 2) of
BRYHALI Lotion patients had achieved treatment success, compared to
8.1 percent and 12 percent of patients receiving vehicle. At four
weeks post treatment, no rebound of symptoms was observed in
patients using BRYHALI Lotion.
BRYHALI Lotion was also found to be well-tolerated, with a
similar number of patients in the BRYHALI Lotion and vehicle groups
reporting adverse events (21.5 percent and 23.9 percent,
respectively). The most common adverse reactions (≥1%) were upper
respiratory tract infection, application site dermatitis and
hyperglycemia.
"Though many psoriasis patients may benefit from longer-term
treatment options, that has typically not been possible with
topical corticosteroids, such as halobetasol, due to concerns about
adverse events," said Francisco
Kerdel, M.D., Florida Academic Dermatology Center. "If
approved, BRYHALI Lotion can provide physicians and their patients
with a new treatment option with a longer duration of
use."
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. BRYHALI Lotion was
formulated containing 0.01 percent halobetasol propionate in a
novel vehicle lotion and was used for up to eight weeks in the
clinical trials.
"At Ortho Dermatologics, we continuously strive to better
understand the evolving needs of dermatology patients and the
providers who treat them each and every day, and we are
accelerating our innovation to ensure our portfolio reflects those
needs," said Bill Humphries,
president and company group chairman, Ortho Dermatologics. "We
believe these new data demonstrate how BRYHALI may benefit many
psoriasis patients, and we look forward to working with the FDA as
the agency completes its review of our New Drug
Application."
The U.S. Food and Drug Administration has accepted the New Drug
Application for BRYHALI Lotion with a Prescription Drug User Fee
Act (PDUFA) action date of October 5,
2018.
About the Phase 3 Studies (Study 1 and 2)
Study 1 and
Study 2 were two multicenter, randomized, double-blind,
vehicle-controlled Phase 3 studies. The studies evaluated the
safety and efficacy of BRYHALI Lotion, compared to vehicle, among
430 patients 18 years or older with an IGA score of three or four,
and affected BSA of three to 12 percent.
Patients were randomized 2:1 to receive BRYHALI Lotion or
vehicle once-daily for eight weeks, with assessments carried out at
two, four, six and eight weeks of treatment, and at a four-week
post treatment follow-up visit. The primary efficacy endpoint was
the percent of patients who were treatment successes at week eight
(defined as those with at least a two-grade improvement from
baseline in IGA score, and 'clear' or 'almost clear' skin). IGA was
assessed by the investigator using a five-point scale ranging from
zero (clear) to four (severe) at each study visit. Secondary
efficacy data were provided at weeks two, four, six and 12. Safety
and treatment emergent adverse events were evaluated
throughout.
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.2 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.3 Plaque psoriasis is the most common type of
psoriasis.4
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 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.
- 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.
* Provisional name
**There are seven classes of steroids; Class 1,
superpotent; Class 2, potent; Class 3, upper mid-strength, Class 4,
mid-strength; Class 5, lower-mid-strength; Class 6, mild; and Class
7, least potent.
BRYHALI is a trademark of Ortho Dermatologics' affiliated
entities.
© 2018 All Rights Reserved.
BRY.0057.USA.18
Investor
Contact:
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Media
Contact:
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Shannon
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Lainie
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(514)
856-3855
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(908)
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