DUOBRII Demonstrated Significant Superiority Over Vehicle As
Early As Two Weeks
LAVAL, Quebec, April 9, 2018 /CNW/ -- Ortho Dermatologics,
a division of Valeant Pharmaceuticals North America, LLC (NYSE/TSX:
VRX), today announced that the Journal of the American Academy
of Dermatology (JAAD) published for the first time positive
results from two Phase 3, multicenter, randomized, double-blind
clinical trials (Studies 1 and 2) to assess the safety and efficacy
of DUOBRIITM1 (halobetasol propionate and tazarotene)
(IDP-118) lotion in the treatment of plaque
psoriasis.2
Studies 1 and 2, which enrolled a total of 418 patients, showed
DUOBRII was consistently more effective than vehicle in achieving
treatment success (defined as those with at least a two-grade
improvement from baseline in an Investigator Global Assessment
(IGA) score, and 'clear' or 'almost clear' skin), demonstrating
statistically significant superiority by week four (in Study 1) and
week two (in Study 2). At week eight, 35.8 percent (Study 1) and
45.3 percent (Study 2) had achieved the primary efficacy outcome,
compared to 7.0 percent and 12.5 percent on vehicle (both
p<0.001). The majority of patients maintained treatment success
over the four-week post treatment period. DUOBRII was also superior
in reducing psoriasis signs and symptoms and body surface area
(BSA) affected compared to vehicle. In addition, DUOBRII showed
significant reductions in the severity of the clinical signs of
psoriasis. The most common treatment-related adverse events were
contact dermatitis (6.3 percent), application site pain (2.6
percent) and pruritus (2.2 percent).
"I've found that psoriasis patients may benefit from combination
therapy with topical agents, many of whom are unsatisfied with
current treatment options," said Linda
Stein Gold, M.D., director, Dermatology Clinical Research,
Henry Ford Health System. "DUOBRII is a fixed dose combination of
halobetasol and tazarotene that has shown synergistic efficacy in
the Phase 2 study. Efficacy was again demonstrated in the two Phase
3 studies versus vehicle with minimal side effects in a
well-tolerated, patient preferred formulation."
Halobetasol propionate and tazarotene, when used separately to
treat plaque psoriasis, are limited to a four-week or less duration
of use and a high rate of adverse events, respectively. Based on
existing data from these and other clinical studies, the
combination of these ingredients in DUOBRII with a dual mechanism
of action, potentially allows for expanded duration of use, with a
proven safety profile.
"Topical corticosteroid treatments are a cornerstone of
psoriasis treatment, but safety concerns have limited their
duration of use for many patients. If approved, DUOBRII will be the
first and only topical lotion that contains a
unique combination of halobetasol propionate and tazarotene in
one formulation," said Bill
Humphries, executive vice president, Dermatology, Ortho
Dermatologics. "We are excited by the hope of what DUOBRII may
offer patients, and we are committed to working with regulatory
authorities to bring this potential new treatment option to market
as quickly as possible."
The U.S. Food and Drug Administration has accepted the New Drug
Application for DUOBRII lotion with a Prescription Drug User Fee
Act (PDUFA) action date of June 18,
2018.
About the Phase 3 Studies (Study 1 and Study 2)
Study
1 and Study 2 were two multicenter, randomized, double-blind,
vehicle-controlled Phase 3 studies. The studies evaluated the
effectiveness of DUOBRII, compared to vehicle among 418 patients 18
years of age and older with an IGA score of three or four, and
affected BSA of three to 12 percent.
Patients were randomized 2:1 to receive DUOBRII or vehicle
once-daily for eight weeks, with a follow-up at four weeks after
discontinuation of active treatment. The primary efficacy endpoint
was the percent of patients who showed treatment success 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 week 12.
Safety and treatment emergent adverse events were evaluated
throughout.
About DUOBRII
DUOBRII (halobetasol propionate and
tazarotene) (IDP-118) lotion is an investigational topical
treatment for plaque psoriasis. If approved, DUOBRII will be the
first and only topical lotion that contains a unique combination of
halobetasol propionate and tazarotene in one formulation for the
treatment of plaque psoriasis in adult patients.
About Ortho Dermatologics
Ortho Dermatologics, a
Valeant Pharmaceuticals International, Inc. company, is one of the
largest prescription dermatology businesses in the world 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 Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX: VRX) 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.valeant.com.
Forward-looking Statements
This press 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
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. 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.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this press release or to reflect actual outcomes,
unless required by law.
1Provisional Name
2 Bulley, et al. "Safety and Efficacy of a
Halobetasol/Tazarotene Fixed Combination in the Treatment of
Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3
Randomized Controlled Trials." Journal of the American
Academy of Dermatology.
© 2018 Valeant Pharmaceuticals North America LLC
Contact
Information:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
514-856-3855
|
908-927-0617
|
877-281-6642 (toll
free)
|
|
View original content with
multimedia:http://www.prnewswire.com/news-releases/ortho-dermatologics-announces-publication-of-pivotal-efficacy-and-safety-data-for-psoriasis-treatment-duobrii-in-the-journal-of-the-american-academy-of-dermatology-300626130.html
SOURCE Valeant Pharmaceuticals International, Inc.