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Ortho Dermatologics
To Present New Data at the 2022 Fall Clinical Dermatology Conference
2022-10-20
·
BioSpace
疫苗
Eleven Poster Presentations Include New Analyses of
ARAZLO
®,
DUOBRII
®, and
IDP-126
Gel LAVAL, QC / ACCESSWIRE / October 20, 2022 /
Bausch Health Companies Inc.
(NYSE:BHC)(TSX:BHC) ("Bausch Health") and its dermatology business,
Ortho Dermatologics
, today announced the presentation of eleven posters during the Fall Clinical Dermatology Conference, which takes place Oct. 20-23, 2022 in Las Vegas, Nev. The presentations will feature new data around
ARAZLO
® (
tazarotene
) Lotion, 0.045%,
DUOBRII
® (
halobetasol propionate
and
tazarotene
) Lotion, 0.01%/0.045%, and the investigational medicine
IDP-126
Gel-a combination retinoid, antibacterial and antibiotic topical. Two other presentations are adaptations featuring research on
SILIQ
® (
brodalumab
) Injection, 210 mg/1.5 mL. Please see below for warning about
suicidal ideation
and behavior with
SILIQ
. There will also be five encore presentations, including a systemic review of
onychomycosis
dermatophytoma treatment. "
Ortho Dermatologics
remains committed to research to ensure the safety and efficacy of our portfolio with patients top of mind," said Richard Lajoie, vice president and general manager, Ortho Dermatologics. "At this year's Fall Clinical Dermatology Conference, we look forward to the opportunity to personally connect with dermatologists to share new data on our investigational
acne
medicine,
IDP-126
Gel, as well as new analyses on two of our prominent
acne
and
psoriasis
medications,
ARAZLO
® and
DUOBRII
®." The complete list of Ortho Dermatologics' poster presentations is as follows:
ARAZLO
® (
tazarotene
) Lotion, 0.045% "Impact of Seasonal Variation on the Efficacy and Safety of
Tazarotene
0.045% Lotion for
Acne
: Post Hoc Analysis of Pooled Phase 3 Data." Draelos et al. "
Tazarotene
0.045% Lotion for
Truncal Acne
: Efficacy, Tolerability, and Spreadability." Kircik et al.
DUOBRII
® (
halobetasol propionate
and
tazarotene
) Lotion, 0.01%/0.045% "Use of Combination
Halobetasol Propionate
/
Tazarotene
Lotion in Difficult-to-Treat
Psoriasis
and
TNF-α
Mechanism of Action." Kircik et al. "Efficacy and Safety of Fixed-Combination
Halobetasol Propionate
and
Tazarotene
Lotion for
Plaque Psoriasis
from Real-World Patient Perspectives" Lain et al. "Fixed-Combination
Halobetasol Propionate
and
Tazarotene
Lotion Decreases
TNF-α
Levels Within Psoriatic Lesions." Draelos et al.
IDP-126
Gel (Investigational Drug) "Benefit of Topical Combination Therapy for
Acne
Treatment: Analysis of Effect Size Using Number Needed to Treat." Feldman et al. "Efficacy and Safety of Triple-Combination
Clindamycin Phosphate
1.2%/Benzoyl Peroxide
3.1%/Adapalene
0.15% Polymeric Mesh Gel in Pediatric Participants." Eichenfield et al.
SILIQ
® (
brodalumab
) Injection, 210 mg/1.5 mL "Unique Mechanism of Action of
Brodalumab
May Correlate With Efficacy vs
Ustekinumab
." Armstrong et al. "Inhibition of
Interleukin-17 Cytokines
With
Brodalumab
May Correlate With Efficacy in Patients With
Psoriasis
and Prior Biologic Exposure." Lain et al. "
Brodalumab
: 4-Year US Pharmacovigilance Report." Lebwohl et al.
JUBLIA
® (
efinaconazole
) Topical Solution, 10% "
Onychomycosis
Dermatophytoma Treatment: A Systematic Review of the Literature." Lipner et al. Important Safety Information for
ARAZLO
® (
tazarotene
) Lotion, 0.045% What is
ARAZLO
?
ARAZLO
® (
tazarotene
) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with
acne
, which can include blackheads, whiteheads, and other pimples. It is not known if
ARAZLO
is safe and effective in children under 9 years of age. Important Safety Information
ARAZLO
is for use on skin only. Do not use
ARAZLO
in your eyes, mouth, the corners of your nose, or vagina. What is the most important information I should know about
ARAZLO
?
ARAZLO
may cause
birth defects
if used during pregnancy. You must not be pregnant when you start using
ARAZLO
or become pregnant during treatment. Use effective birth control during treatment. Stop using
ARAZLO
and tell your healthcare provider right away if you become pregnant during treatment. Before using
ARAZLO
, tell your healthcare provider about all your medical conditions, including if you: have
eczema
or any other skin problems. are breastfeeding or plan to breastfeed. If you use
ARAZLO
while breastfeeding, use it for the shortest time needed. Do not apply
ARAZLO
directly to the nipple and surrounding area to avoid exposing your child to the medicine. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure. Especially tell your healthcare provider about other products you use on your skin (such as
benzoyl peroxide
), including moisturizers, creams, lotions, or products that can dry out your skin. What should I avoid while using
ARAZLO
? You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with
ARAZLO
. Minimize exposure to sunlight; you could get severe
sunburn
. If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas. Avoid using
ARAZLO
on skin with
eczema
or sunburned skin because it may cause severe irritation.
ARAZLO
may cause side effects, including:
Skin irritation
.
ARAZLO
may cause irritation including
skin dryness
,
pain
,
redness
, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with
ARAZLO
. These are not all the possible side effects of
ARAZLO
. 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 . Click here for full Prescribing Information, including Patient Information. Important Safety Information for
DUOBRII
® (
halobetasol propionate
and
tazarotene
) Lotion, 0.01%/0.045% What is
DUOBRII
® Lotion? DUOBRII (
halobetasol propionate
and
tazarotene
) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with
plaque psoriasis
. It is not known if
DUOBRII
Lotion is safe and effective in children. Important Safety Information
DUOBRII
Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina. What is the most important Information I should know about DUOBRII Lotion?
DUOBRII Lotion
may cause
birth defects
if used during pregnancy. A negative pregnancy test must be obtained before females of child-bearing age start using DUOBRII Lotion and they must use effective birth control during treatment. Begin treatment during a normal menstrual period. Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion. Before you use
DUOBRII
Lotion, tell your healthcare provider if you: have
eczema
or any other
skin problems
, including
skin infections
, which may need to be treated before using
DUOBRII
. have
diabetes
, adrenal gland problems or liver problems. are breastfeeding or plan to breastfeed. If you use
DUOBRII
and breastfeed, do not apply
DUOBRII
to your nipple area. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take corticosteroids by mouth or injection or use other skin products that contain corticosteroids. Ask your healthcare provider for a list of medicines that may make your skin more sensitive to sunlight. What should I avoid during treatment with
DUOBRII
? To avoid a severe
sunburn
, avoid sunlight, including sunlamps and tanning beds, as much as possible, and use sunscreen, protective clothing and a hat while in sunlight. Talk to your healthcare provider if you get
sunburn
, and do not use DUOBRII Lotion until your
sunburn
is healed. Avoid using
DUOBRII
on skin with
eczema
because it may cause severe irritation.
DUOBRII
may cause side effects, including: If too much
DUOBRII
passes through your skin it can cause adrenal glands to stop working
Cushing's syndrome
, a condition from too much exposure to the hormone cortisol High blood sugar (hyperglycemia) Effects of growth and weight in children
Skin irritation
. If you get too much
skin irritation
at the site of application, your healthcare provider may tell you to interrupt or stop using
DUOBRII
or to use it less often. Vision problems, including an increased chance of developing
cataracts
and
glaucoma
. Tell your healthcare provider about any vision problems during treatment. The most common side effects of
DUOBRII
Lotion include:
redness
,
itching
,
swelling
, burning, stinging,
application site pain
, inflamed hair follicles (
folliculitis
), thinning of the skin (
atrophy
), peeling and
rash
. To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit . This is not all of the Important Safety Information you need to know about
DUOBRII
; please click here for full Prescribing Information, including Patient Information. Important Safety Information for
SILIQ
® (
brodalumab
) Injection, 210 mg/1.5 mL What is SILIQ?
SILIQ
® injection is a prescription medicine used to treat adults with moderate to severe
plaque psoriasis
: who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and who have tried another systemic therapy that didn't work or stopped working It is not known if
SILIQ
is safe and effective in children. What is the most important information I should know about SILIQ? Suicidal thoughts or behavior: Some patients taking
SILIQ
have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or
depression
. It is not known if
SILIQ
causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening
depression
,
anxiety
, or
mood problems
thoughts of suicide, dying, or hurting yourself attempt to commit suicide, or acting on dangerous impulses other unusual changes in your behavior or mood Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with
SILIQ
and show it to all of your healthcare providers. Serious
Infections
:
SILIQ
may lower the ability of your immune system to fight
infections
and may increase your risk of
infections
: Your healthcare provider should check you for
tuberculosis (TB)
before starting treatment with
SILIQ
and may treat you for
TB
before starting
SILIQ
if you have
TB
or a history of it You and your healthcare provider need to watch closely for signs and symptoms of
infection
during treatment with
SILIQ
, including
fever
, sweats, chills,
shortness of breath
,
stomach issues
,
muscle aches
,
cough
,
sore throat
or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination Who should not use
SILIQ
? Do not use SILIQ if you have
Crohn's disease
. Tell your healthcare provider if you develop
diarrhea
,
bloody stools
,
stomach pain
or
cramping
, sudden or uncontrollable bowel movements,
loss of appetite
,
constipation
,
weight loss
,
fever
or tiredness as these may be symptoms of
Crohn's disease
. Before starting SILIQ, tell your healthcare provider if you: have a history of mental health problems, including
suicidal thoughts
,
depression
,
anxiety
, or
mood problems
have an
infection
that does not go away or keeps coming back have
TB
or have been in close contact with someone with
TB
have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with
SILIQ
are or plan to become pregnant, or are breastfeeding or plan to do so. It is unknown if
SILIQ
can harm your unborn or newborn baby Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use SILIQ? See the detailed "Instructions for Use" that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes. Use SILIQ exactly as your healthcare provider tells you to use it. What are possible side effects of
SILIQ
?
SILIQ
may cause serious side effects. See "What is the most important information I should know about SILIQ?" and "Who should not take SILIQ?" The most common side effects of
SILIQ
include:
Joint pain
Muscle pain Headache
Injection site reactions
Tiredness Flu Diarrhea Low white blood cell count (
neutropenia
) Mouth or throat pain
Fungal infections
of the skin Nausea Call your doctor for medical advice on side effects. You are encouraged to report negative side effects of prescription drugs to Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit . Please click here for accompanying full Prescribing Information, including Boxed Warning about
suicidal ideation
and behavior, and Medication Guide. Important Safety Information for
JUBLIA
® (
efinaconazole
) Topical Solution, 10% INDICATION
JUBLIA
(
efinaconazole
) Topical Solution, 10% is a prescription medicine used to treat
fungal infections
of the toenails. IMPORTANT SAFETY INFORMATION
JUBLIA
is for use on nails and surrounding skin only. Do not use
JUBLIA
in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor. The safety and efficacy of
JUBLIA
have not been established in children under six years old. Before you use
JUBLIA
, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether
JUBLIA
can harm an unborn fetus or nursing infant. Tell your doctor about all medications you are taking, and whether you have any other
nail infections
.
JUBLIA
is flammable. Avoid heat and flame while applying
JUBLIA
to your toenail.
JUBLIA
may cause irritation at the treated site. The most common side effects include: ingrown toenail,
redness
,
itching
,
swelling
, burning or stinging,
blisters
, and
pain
. Tell your doctor about any side effects that bother you or do not go away. To report SUSPECTED ADVERSE REACTIONS, contact
Ortho Dermatologics
at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit . Please click here for full Prescribing Information, including Patient Information. Visit to learn more. 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 therapeutic areas, including
psoriasis
,
onychomycosis
,
actinic keratosis
,
acne
,
atopic dermatitis
and other
dermatoses
. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. 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 of
Bausch + Lomb Corporation
. 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, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "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, the risks and uncertainties discussed 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. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving
COVID-19 pandemic
, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). 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. ARAZLO, DUOBRII, SILIQ, and JUBLIA are trademarks of
Ortho Dermatologics
' affiliated entities.
Ortho Dermatologics
is a trademark of
Ortho Dermatologics
' affiliated entities. © 2022
Ortho Dermatologics
' affiliated entities. ORD.0136.USA.22
Bausch Health Investor
Contact: Christina Cheng ir@bauschhealth.com
Bausch Health Media
Contact: Kevin Wiggins corporate.communications@bauschhealth.com SOURCE:
Bausch Health Companies Inc.
View source version on accesswire.com:
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机构
Ortho Dermatologics
Bausch & Lomb, Inc.
Bausch Health US LLC
[+1]
适应症
湿疹
腹痛
白内障
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