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CABTREO(T
M) (
clindamycin phosphate
,
adapalene
and
benzoyl peroxide
) Topical Gel for the Treatment of
Acne Vulgaris
Now Available in the U.S.
2024-01-30
·
BioSpace
临床3期
临床结果
上市批准
LAVAL, QC / ACCESSWIRE / January 30, 2024 /
Bausch Health Companies Inc.
(NYSE:BHC)(TSX:BHC) and its dermatology business,
Ortho Dermatologics
, today announced the U.S. launch of
CABTREO
™ (
clindamycin
,
adapalene
,
benzoyl peroxide
) Topical Gel, 1.2%/0.15%/3.1% indicated for the topical treatment of
acne vulgaris
in patients 12 years of age and older. "With today's launch of CABTREO, millions of Americans who suffer from
acne
each year have access to a new once-daily triple-combination topical
acne
treatment," Thomas J. Appio, Chief Executive Officer, said. "In many instances,
acne
treatment requires using multiple products and dosing regimens, which can pose a number of challenges for patients.
CABTREO
has the potential to simplify dosing with a once daily topical acne treatment regimen."
CABTREO
Topical Gel is the first and only
U.S. Food and Drug Administration
-approved fixed-dose, once-daily triple-combination topical treatment for
acne
and offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. The FDA approved
CABTREO
Topical Gel on Oct. 20, 2023, based on data from two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated
CABTREO
Topical Gel resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. At week 12, 50.0% of participants achieved treatment success with
CABTREO
versus 22.6% with vehicle gel (P<0.001).
CABTREO
resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9%% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P<0.001, both). The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were
application site reactions
,
pain
,
erythema
,
dryness
, irritation, exfoliation, and
dermatitis
. About
Acne Vulgaris
Acne
is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have
acne.2
Depending on its severity,
acne
can cause emotional distress and scar the skin.2 What is CABTREO?
CABTREO
(
clindamycin phosphate
,
adapalene
and
benzoyl peroxide
) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat
acne vulgaris
in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina. IMPORTANT SAFETY INFORMATION Do not use
CABTREO
if you have had an
allergic reaction
to
clindamycin
,
adapalene
,
benzoyl peroxide
,
lincomycin
, or any of the ingredients in
CABTREO
or have
Crohn's disease
,
ulcerative colitis
,
inflammation of the colon (colitis)
, or severe
diarrhea
with antibiotic use. Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions,
sunburn
, or
eczema
; or use other skin and topical
acne
products that may increase the irritation of your skin when used with CABTREO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains
erythromycin
.
CABTREO
should not be used with products that contain
erythromycin
. What should I avoid while using CABTREO? Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe
sunburn
. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight. Cold weather and wind may irritate skin treated with CABTREO. Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or
eczema
. Avoid skin products that may dry or irritate your skin. Avoid the use of "waxing" as a hair removal method on skin treated with CABTREO. What are the possible serious and most common side effects of
CABTREO
? Tell your doctor right away if you experience side effects, including:
Allergic reactions
: Stop using CABTREO if you have
hives
,
rash
, severe
itching
,
swelling
of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded.
Inflammation
of the colon (
colitis
): Stop using
CABTREO
if you have severe stomach (abdominal) cramps,
watery diarrhea
, or
bloody diarrhea
during treatment, and within several weeks after treatment with
CABTREO
. Sensitivity to sunlight. See "What should I avoid while using CABTREO".
Skin irritation
at the application site is common with CABTREO and may include
redness
, scaling,
dryness
, stinging, burning,
itching
, and
swelling
. These are not all the possible side effects of
CABTREO
. Call your doctor for medical advice about side effects. You may report side effects to
Bausch Health US, LLC
at 1-800-321-4576 or FDA at 1-800-FDA- 1088 or Please click here for full Prescribing Information, Patient Information and Instructions for Use. About
Ortho Dermatologics
Ortho Dermatologics
is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including
psoriasis
,
onychomycosis
,
actinic keratosis
,
acne
,
atopic dermatitis
and other
dermatoses
. More information can be found at . About
Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Forward-Looking Statements This news release may contain forward-looking statements about the future performance of
Bausch Health
which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" 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. Actual results are subject to other risks and uncertainties that relate more broadly to
Bausch Health
's overall business, including those more fully described in
Bausch Health
's most recent annual report on Form 10-K and detailed from time to time in
Bausch Health
's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. References 1. American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from . Accessed March13, 2023. 2. Mayo Clinic. (2020).
Acne
. Retrieved from . Accessed March 13, 2023. Investor Contact: ir@bauschhealth.com (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (848) 541-3785 ###
CABTREO
™ is a trademark of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities. © 2024 Ortho Dermatologics' affiliated entities. CAB.0025.USA.24 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com
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机构
Bausch Health Cos., Inc.
Ortho Dermatologics, Inc.
US Food & Drug Administration
[+1]
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