Key presentations include topline safety,
efficacy and patient satisfaction data from the 52-week, open label
EMERGENT-4 and EMERGENT-5 clinical trials evaluating COBENFY™
(xanomeline and trospium chloride) for the treatment of
schizophrenia in adults
Additional presentations to include
schizophrenia focused disease-state and Health Economics and
Outcomes Research (HEOR)
Bristol Myers Squibb (NYSE: BMY) today announced that new
clinical and health economics and outcomes research data (HEOR)
from its neuropsychiatry portfolio evaluating COBENFY™ (xanomeline
and trospium chloride) in schizophrenia in adults will be presented
at Psych Congress 2024, taking place October 29 – November 2 in
Boston, Massachusetts.
“Building on momentum from the recent U.S. Food and Drug
Administration’s approval of COBENFY for the treatment of
schizophrenia in adults, we’re pleased to be sharing additional
data at Psych Congress from the EMERGENT clinical trial program
that further highlights the differentiated clinical profile of
COBENFY, including efficacy, safety, and patient reported outcomes
of adults with schizophrenia who participated in our long-term
clinical trials,” said Alyssa Johnsen, MD, PhD, senior vice
president and head of clinical development, Immunology,
Cardiovascular and Neuroscience, Bristol Myers Squibb. “As we
continue to strengthen our neuropsychiatry portfolio, we remain
committed to developing and delivering differentiated options for
patients.”
Research to be presented at the meeting continues to demonstrate
COBENFY as a differentiated treatment option for adults living with
schizophrenia. Notable data poster presentations include:
Clinical:
- Long-Term Safety and Efficacy of Xanomeline and Trospium
Chloride in Schizophrenia: Results from the 52-Week, Open-Label
EMERGENT-4 Trial
- Long-Term Safety, Tolerability, and Efficacy of Xanomeline and
Trospium Chloride in People with Schizophrenia: Results From the
52-Week, Open-Label EMERGENT-5 Trial
- Patient Satisfaction with Xanomeline and Trospium Chloride
Treatment for Schizophrenia: A Qualitative Interview-Based
Study
- Changes in Quality of Life for Schizophrenia Outpatients
Receiving the Muscarinic Agonist Xanomeline and Trospium: Findings
of a Qualitative Interview-Based Study
HEOR:
- Negative symptoms and cognitive impairment in US patients with
schizophrenia: a real-world descriptive study using the NeuroBlu
database
- Comparative Efficacy, Safety, and Tolerability of Xanomeline
and Trospium Chloride versus Eight Atypical Antipsychotics for the
Acute Treatment of Adults with Schizophrenia – A Network
Meta-Analysis
- Current Estimates of the Incidence and Prevalence of
Schizophrenia in the U.S.
A full list of Bristol Myers Squibb presentations at Psych
Congress is below. All presentations will take place in the Exhibit
Hall on Thursday, October 31 and Friday, November 1 from 1:30 –
3:00 p.m. ET. For more information, please visit the Psych Congress
website here.
Abstract Title
Primary Author
Type
Clinical Data
Long-Term Safety and Efficacy of
Xanomeline and Trospium Chloride in Schizophrenia: Results from the
52-Week, Open-Label EMERGENT-4 Trial
Kaul, I.
Poster
Long-Term Safety, Tolerability, and
Efficacy of Xanomeline and Trospium Chloride in People with
Schizophrenia: Results From the 52-Week, Open-Label EMERGENT-5
Trial
Kaul, I.
Poster
Patient Satisfaction with Xanomeline and
Trospium Chloride Treatment for Schizophrenia: A Qualitative
Interview-Based Study
Horan, W.
Poster
Changes in Quality of Life for
Schizophrenia Outpatients Receiving the Muscarinic Agonist
Xanomeline and Trospium: Findings of a Qualitative Interview-Based
Study
Weiden, P.
Poster
Efficacy of Xanomeline and Trospium
Chloride in Schizophrenia: Post Hoc Analyses of Data Pooled From
Three 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT
Trials
Kaul, I.
Poster
Xanomeline and Trospium Chloride for the
Treatment of Agitation in Schizophrenia: PANSS-EC Results From
Three Randomized, Double-Blind, Placebo-Controlled Trials
Yeung, P.
Poster
Long-Term Metabolic Outcomes Associated
With Xanomeline and Trospium Chloride: Interim Results From Pooled,
Long-Term Safety Studies EMERGENT-4 and EMERGENT-5
Claxton, A.
Poster
Assessing Participant Experience With
Xanomeline and Trospium Chloride Treatment Using In-Trial
Qualitative Interviews: Perceived Effect on Symptoms During a
Long-Term Phase 3 Trial in Schizophrenia
Horan, W.
Poster
Health Economics and Outcomes
Research
Negative symptoms and cognitive impairment
in US patients with schizophrenia: a real-world descriptive study
using the NeuroBlu database
Lipunova, N., Holmusk
Technologies, Inc.
Poster
Comparative Efficacy, Safety, and
Tolerability of Xanomeline and Trospium Chloride versus Eight
Atypical Antipsychotics for the Acute Treatment of Adults with
Schizophrenia – A Network Meta-Analysis
Hickey, C., Lumanity
Poster
Current Estimates of the Incidence and
Prevalence of Schizophrenia in the U.S.
Cajigal, A.
Poster
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness
impacting how a person thinks, feels and behaves. There are three
symptom domains of schizophrenia, which include positive symptoms
(e.g., hallucinations, delusions, disordered thinking and speech),
negative symptoms (e.g., lack of motivation, lack of emotional
expression/flat affect, social withdrawal) and cognitive
dysfunction (e.g., impaired attention, deficits in memory,
concentration and decision-making). The symptoms of schizophrenia
can affect all areas of people’s lives, making it difficult to
maintain employment, live independently and manage relationships.
Schizophrenia affects nearly 24 million people worldwide, including
2.8 million people in the United States, and is one of the top 15
leading causes of disability worldwide.
About COBENFY™ (xanomeline and trospium chloride)
COBENFY™ (xanomeline and trospium chloride), formerly KarXT, is
an oral medication for the treatment of schizophrenia in adults.
COBENFY combines xanomeline, a dual M1- and M4-preferring
muscarinic receptor agonist, with trospium chloride, a muscarinic
receptor antagonist that does not appreciably cross the blood-brain
barrier, primarily confining its effects to peripheral tissues.
While the exact mechanism of action of COBENFY is unknown, its
efficacy is thought to be due to the agonist activity of xanomeline
at M1 and M4 muscarinic acetylcholine receptors in the central
nervous system.
INDICATION
COBENFY™ (xanomeline and trospium chloride) is indicated for the
treatment of schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COBENFY is contraindicated in patients with:
- urinary retention
- moderate (Child-Pugh Class B) or severe (Child-Pugh Class C)
hepatic impairment
- gastric retention
- history of hypersensitivity to COBENFY or trospium chloride.
Angioedema has been reported with COBENFY and trospium
chloride.
- untreated narrow-angle glaucoma
WARNINGS AND PRECAUTIONS
Risk of Urinary Retention: COBENFY can cause urinary
retention. Geriatric patients and patients with clinically
significant bladder outlet obstruction and incomplete bladder
emptying (e.g., patients with benign prostatic hyperplasia (BPH),
diabetic cystopathy) may be at increased risk of urinary
retention.
COBENFY is contraindicated in patients with pre-existing urinary
retention and is not recommended in patients with moderate or
severe renal impairment.
In patients taking COBENFY, monitor for symptoms of urinary
retention, including urinary hesitancy, weak stream, incomplete
bladder emptying, and dysuria. Instruct patients to be aware of the
risk and promptly report symptoms of urinary retention to their
healthcare provider. Urinary retention is a known risk factor for
urinary tract infections. In patients with symptoms of urinary
retention, consider reducing the dose of COBENFY, discontinuing
COBENFY, or referring patients for urologic evaluation as
clinically indicated.
Risk of Use in Patients with Hepatic Impairment: Patients
with hepatic impairment have higher systemic exposures of
xanomeline, a component of COBENFY, compared to patients with
normal hepatic function, which may result in increased incidence of
COBENFY-related adverse reactions.
COBENFY is contraindicated in patients with moderate or severe
hepatic impairment. COBENFY is not recommended in patients with
mild hepatic impairment.
Assess liver enzymes prior to initiating COBENFY and as
clinically indicated during treatment.
Risk of Use in Patients with Biliary Disease: In clinical
studies with COBENFY, transient increases in liver enzymes with
rapid decline occurred, consistent with transient biliary
obstruction due to biliary contraction and possible gallstone
passage.
COBENFY is not recommended for patients with active biliary
disease such as symptomatic gallstones. Assess liver enzymes and
bilirubin prior to initiating COBENFY and as clinically indicated
during treatment. The occurrence of symptoms such as dyspepsia,
nausea, vomiting, or upper abdominal pain should prompt assessment
for gallbladder disorders, biliary disorders, and pancreatitis, as
clinically indicated.
Discontinue COBENFY in the presence of signs or symptoms of
substantial liver injury such as jaundice, pruritus, or alanine
aminotransferase levels more than five times the upper limit of
normal or five times baseline values.
Decreased Gastrointestinal Motility: COBENFY contains
trospium chloride. Trospium chloride, like other antimuscarinic
agents, may decrease gastrointestinal motility. Administer COBENFY
with caution in patients with gastrointestinal obstructive
disorders because of the risk of gastric retention. Use COBENFY
with caution in patients with conditions such as ulcerative
colitis, intestinal atony, and myasthenia gravis.
Risk of Angioedema: Angioedema of the face, lips, tongue,
and/or larynx has been reported with COBENFY and trospium chloride,
a component of COBENFY. In one case, angioedema occurred after the
first dose of trospium chloride. Angioedema associated with upper
airway swelling may be life-threatening. If involvement of the
tongue, hypopharynx, or larynx occurs, discontinue COBENFY and
initiate appropriate therapy and/or measures necessary to ensure a
patent airway. COBENFY is contraindicated in patients with a
history of hypersensitivity to trospium chloride.
Risk of Use in Patients with Narrow-angle Glaucoma:
Pupillary dilation may occur due to the anticholinergic effects of
COBENFY. This may trigger an acute angle closure attack in patients
with anatomically narrow angles. In patients known to have
anatomically narrow angles, COBENFY should only be used if the
potential benefits outweigh the risks and with careful
monitoring.
Increases in Heart Rate: COBENFY can increase heart rate.
Assess heart rate at baseline and as clinically indicated during
treatment with COBENFY.
Anticholinergic Adverse Reactions in Patients with Renal
Impairment: Trospium chloride, a component of COBENFY, is
substantially excreted by the kidney. COBENFY is not recommended in
patients with moderate or severe renal impairment (estimated
glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure
of trospium chloride is higher in patients with moderate and severe
renal impairment. Therefore, anticholinergic adverse reactions
(including dry mouth, constipation, dyspepsia, urinary tract
infection, and urinary retention) are expected to be greater in
patients with moderate and severe renal impairment.
Central Nervous System Effects: Trospium chloride, a
component of COBENFY, is associated with anticholinergic central
nervous system (CNS) effects. A variety of CNS anticholinergic
effects have been reported with trospium chloride, including
dizziness, confusion, hallucinations, and somnolence. Monitor
patients for signs of anticholinergic CNS effects, particularly
after beginning treatment or increasing the dose. Advise patients
not to drive or operate heavy machinery until they know how COBENFY
affects them. If a patient experiences anticholinergic CNS effects,
consider dose reduction or drug discontinuation.
Most Common Adverse Reactions (≥5% and at least twice
placebo): nausea, dyspepsia, constipation, vomiting,
hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and
gastroesophageal reflux disease.
Use in Specific Populations:
- Moderate or Severe Renal Impairment: Not recommended
- Mild Hepatic Impairment: Not recommended
COBENFY (xanomeline and trospium chloride) is available in
50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.
Please see U.S. Full Prescribing Information,
including Patient Information.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on current expectations and projections about our future
financial results, goals, plans and objectives and involve inherent
risks, assumptions and uncertainties, including internal or
external factors that could delay, divert or change any of them in
the next several years, that are difficult to predict, may be
beyond our control and could cause our future financial results,
goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks,
assumptions, uncertainties and other factors include, among others,
that future study results may not be consistent with the results to
date and that COBENFY (xanomeline and trospium chloride) may not
achieve its primary study endpoints or receive regulatory approval
for the indications described in this release in the currently
anticipated timeline or at all, any marketing approvals, if
granted, may have significant limitations on their use, and, if
approved, whether COBENFY for such indications will be commercially
successful. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2023, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
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