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Salix Will Present
XIFAXAN(R)
(
Rifaximin
), TRULANCE(R) (
Plecanatide
) and RELISTOR(R) (
Methylnaltrexone Bromide
) Data at The American
College of Gastroenterology
(R) 2022 Annual Scientific Meeting
2022-10-24
·
BioSpace
LAVAL, QC / ACCESSWIRE / October 24, 2022 /
Bausch Health Companies Inc.
(NYSE:BHC)(TSX:BHC) ("Bausch Health") and its gastroenterology business,
Salix Pharmaceuticals, Ltd.
("Salix"), today announced four posters and one abstract featuring data for
XIFAXAN
® (
rifaximin
),
TRULANCE
® (
plecanatide
) and
RELISTOR
® (
methylnaltrexone bromide
) that are being presented at the American College of Gastroenterology® (ACG) 2022 Annual Scientific Meeting, which is taking place October 21-26 in Charlotte, North Carolina. The complete list of Salix research being featured at ACG 2022 includes: XIFAXAN Staller, Kyle et al. "The Strong Association Between
Bloating
,
Abdominal Pain
, and Global
Irritable Bowel Syndrome
Symptom Scores in
IBS
With
Diarrhea
: A Phase 3 Trial Pooled Correlation Analysis of Individual Symptoms." Cash, Brooks D. et al. "
Rifaximin
Improves Both
Fecal Urgency
and Stool Consistency in Adults With
Irritable Bowel Syndrome
With
Diarrhea
: A Composite Endpoint Analysis of Two Randomized, Phase 3 Trials." TRULANCE Sayuk, Gregory S. et al. "
Plecanatide
Improves Severe
Abdominal Pain
and Severe
Bloating
in Individuals With
Irritable Bowel Syndrome
With
Constipation
: A Pooled Analysis of Two Phase 3 Trials." Staller, Kyle et al. "
Plecanatide
Improves Symptoms of
Chronic Idiopathic Constipation
and
Irritable Bowel Syndrome
With
Constipation
Across Age Subgroups: an Analysis of Four Phase 3 Trials." RELISTOR Shah, Mehta N, et al. "Impact of Patient Subgroups on the Efficacy and Safety of
Methylnaltrexone
for
Opioid-induced Constipation
in Patients With Advanced Illness." About
XIFAXAN
® Indications
XIFAXAN
® (
rifaximin
) 550 mg tablets are indicated for the reduction in risk of
overt hepatic encephalopathy (HE)
recurrence in adults and for the treatment of
irritable bowel syndrome
with
diarrhea (IBS-D)
in adults. IMPORTANT SAFETY INFORMATION
XIFAXAN
is contraindicated in patients with a
hypersensitivity
to
rifaximin
,
rifamycin antimicrobial agents
, or any of the components in
XIFAXAN
. Hypersensitivity reactions have included
exfoliative dermatitis
,
angioneurotic edema
, and
anaphylaxis
.
Clostridium difficile-associated diarrhea (CDAD)
has been reported with use of nearly all antibacterial agents, including
XIFAXAN
, and may range in severity from mild
diarrhea
to fatal
colitis
. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering
XIFAXAN
to these patients. Caution should be exercised when concomitant use of
XIFAXAN
and
P-glycoprotein (P-gp)
and/or
OATPs
inhibitors is needed. Concomitant administration of
cyclosporine
, an inhibitor of
P-gp
and
OATPs
, significantly increased the systemic exposure of
rifaximin
. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant
P-gp
inhibitors may further increase the systemic exposure to
rifaximin
. In clinical studies, the most common adverse reactions for
XIFAXAN
were: HE (≥10%):
Peripheral edema
(15%),
nausea
(14%),
dizziness
(13%),
fatigue
(12%), and
ascites
(11%)
IBS-D
(≥2%):
Nausea
(3%), ALT increased (2%) INR changes have been reported in patients receiving
rifaximin
and
warfarin
concomitantly. Monitor INR and prothrombin time. Dose adjustment of
warfarin
may be required.
XIFAXAN
may cause fetal harm. Advise pregnant women of the potential risk to a fetus. To report SUSPECTED ADVERSE REACTIONS, contact
Salix Pharmaceuticals
at 1-800-321-4576 or FDA at 1-800-FDA-1088 or . Please click here for full Prescribing Information. About
TRULANCE
Indication
Trulance (plecanatide)
3 mg tablets is indicated in adults for the treatment of
Chronic Idiopathic Constipation (CIC)
and
Irritable Bowel Syndrome
with
Constipation (IBS-C)
. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS
DEHYDRATION
IN PEDIATRIC PATIENTS
Trulance
® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of
plecanatide
caused deaths due to
dehydration
. Use of
Trulance
should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of
Trulance
have not been established in pediatric patients less than 18 years of age. Contraindications
Trulance
is contraindicated in patients less than 6 years of age due to the risk of serious
dehydration
.
Trulance
is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction
. Warnings and Precautions Risk of Serious
Dehydration
in Pediatric Patients
Trulance
is contraindicated in patients less than 6 years of age. The safety and effectiveness of
Trulance
in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years),
plecanatide
increased fluid secretion as a consequence of stimulation of
guanylate cyclase-C (GC-C)
, resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of
GC-C
, patients less than 6 years of age may be more likely than older patients to develop severe
diarrhea
and its potentially serious consequences. Use of
Trulance
should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of
Trulance
should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea
was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and
IBS-C
. Severe
diarrhea
was reported in 0.6% of
Trulance
-treated CIC patients, and in 1% of
Trulance
-treated
IBS-C
patients. If severe
diarrhea
occurs, the health care provider should suspend dosing and rehydrate the patient. Adverse Reactions In the two combined CIC clinical trials, the most common adverse reaction in
Trulance
-treated patients (incidence ≥2% and greater than in the placebo group) was
diarrhea
(5% vs 1% placebo). In the two combined
IBS-C
clinical trials, the most common adverse reaction in
Trulance
-treated patients (incidence ≥2% and greater than in the placebo group) was
diarrhea
(4.3% vs 1% placebo). Please also see the full Prescribing Information, including BOXED Warning, for additional risk information. About RELISTOR INDICATIONS
RELISTOR
® (
methylnaltrexone bromide
) is an opioid antagonist.
RELISTOR
tablets and
RELISTOR
injection are indicated for the treatment of
opioid-induced constipation (OIC)
in adults with
chronic non-cancer pain
, including patients with
chronic pain
related to prior
cancer
or its treatment who do not require frequent (e.g., weekly)
opioid
dosage escalation.
RELISTOR
injection is also indicated for the treatment of
OIC
in adults with advanced illness or
pain
caused by active
cancer
who require
opioid
dosage escalation for palliative care. IMPORTANT SAFETY INFORMATION RELISTOR tablets and injection are contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction
and patients at increased risk of
recurrent obstruction
, due to the potential for
gastrointestinal perforation
. Cases of
gastrointestinal perforation
have been reported in adult patients with
opioid-induced constipation
and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g.,
peptic ulcer disease
,
Ogilvie
Ogilvie's syndrome
,
diverticular disease
,
infiltrative gastrointestinal tract malignancies
or
peritoneal metastases
). Take into account the overall risk-benefit pro using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g.,
Crohn's disease
). Monitor for the development of severe, persistent, or worsening
abdominal pain
; discontinue RELISTOR in patients who develop this symptom. If severe or persistent
diarrhea
occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider. Symptoms consistent with opioid withdrawal, including
hyperhidrosis
, chills,
diarrhea
,
abdominal pain
,
anxiety
, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal. Avoid concomitant use of
RELISTOR
with other
opioid antagonists
because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal. The use of
RELISTOR
during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. A dosage reduction of
RELISTOR
tablets and
RELISTOR
injection is recommended in patients with moderate and severe
renal impairment
(creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of
RELISTOR
tablets or
RELISTOR
injection is needed in patients with mild
renal impairment
. A dosage reduction of
RELISTOR
tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of
RELISTOR
tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of
RELISTOR
injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for
methylnaltrexone
-related adverse reactions and dose adjust per Prescribing Information as may be indicated. In the clinical studies, the most common adverse reactions were: OIC in adult patients with
chronic non-cancer pain
RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo):
abdominal pain
(14%),
diarrhea
(5%),
headache
(4%),
abdominal distention
(4%),
vomiting
(3%),hyperhidrosis
(3%),anxiety
(2%),
muscle spasms
(2%), rhinorrhea (2%), and chills (2%).
RELISTOR
injection (≥ 1% of
RELISTOR
patients and at a greater incidence than placebo):
abdominal pain
(21%),
nausea
(9%),diarrhea
(6%),
hyperhidrosis
(6%),
hot flush
(3%),tremor
(1%), and chills (1%). OIC in adult patients with advanced illness RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo):
abdominal pain
(29%)
flatulence
(13%),
nausea
(12%),dizziness
(7%), and
diarrhea
(6%). To report SUSPECTED ADVERSE REACTIONS, contact
Salix Pharmaceuticals
at 1-800-321-4576 or FDA at 1-800- FDA-1088 or [Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.] OR [Please see accompanying full Prescribing Information for
RELISTOR
tablets and RELISTOR injection.] About
Salix
Salix Pharmaceuticals
is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of
gastrointestinal diseases
. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology,
pain
specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. 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. Forward-looking Statements This news release may contain forward-looking statements about the future performance of the Company, 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 the Company's overall business, including those more fully described in the Company's most recent annual report on Form 10-K and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference. Investor Contact: Christina Cheng ir@bauschhealth.com (514) 856-3855 (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 Gianna Scalera salixcommunications@bauschhealth.com (908) 541-2110 ©2022
Salix Pharmaceuticals
or its affiliates. TRULANCE and RELISTOR are trademarks of
Salix Pharmaceuticals
or its affiliates. The
XIFAXAN
550 mg product and the
XIFAXAN
trademark are licensed by
Alfasigma
S.p.A. to
Salix Pharmaceuticals
or its affiliates. SAL.0113.USA.22 SOURCE:
Bausch Health Companies Inc.
View source version on accesswire.com:
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机构
American College of Gastroenterology
Salix Pharmaceuticals, Inc.
The Ogilvie Charities (Deed No. 1)
[+4]
适应症
腹痛
大便失禁
疼痛
[+39]
靶点
P-gp
OATP
NPRC
[+1]
药物
利福昔明
普卡那肽
溴化甲基纳曲酮
[+5]
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