DUBLIN, May 15, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company, today
announced it will showcase data during the upcoming American
Psychiatric Association (APA) Annual Meeting in San Francisco, May
18 – May 22, 2019. Data being
presented include research on VRAYLAR® (cariprazine)
that investigates its use for the treatment of depressive episodes
associated with bipolar I disorder (bipolar depression) in adult
patients.
"We are looking forward to sharing data at APA this year that
further support the value of VRAYLAR, which now has 10 positive
pivotal trials across bipolar I disorder and schizophrenia," said
David Nicholson, Chief Research
& Development Officer at Allergan. "We are particularly
encouraged by the data related to bipolar depression. The potential
to treat the full spectrum of bipolar I symptoms, specifically,
manic, mixed and depressive episodes, with a single agent, presents
an opportunity to streamline treatment decisions for this
complicated disorder."
Cariprazine data for bipolar I disorder and cognition symptoms
in schizophrenia will be featured in two posters at APA, which will
be presented by two leading psychiatry experts, Stephen M. Stahl and Roger S. McIntyre. The titles of the poster
presentations are as follows – all noted in local Pacific Time
(PT):
Tuesday, May 21, 2019
- Cariprazine Efficacy in Patients With Bipolar Depression and
Concurrent Manic Symptoms: Post Hoc Analysis of 3 Randomized,
Placebo-Controlled Studies (#P8-080). Presented by Stephen M. Stahl (2:00
p.m. – 4:00 p.m. PT, Moscone
South, Exhibition Level, Room 3-4).
- Effects of Cariprazine on Attentional Processes in Patients
With Schizophrenia: Post Hoc Analysis From a Randomized, Controlled
Phase III Study (#P7-043). Presented by Roger S. McIntyre (10:00
a.m. – 12:00 p.m. PT, Moscone
South, Exhibition Level, Room 3-4).
Cariprazine was approved by the FDA in September 2015 and is marketed as VRAYLAR in the
U.S. for the acute treatment of manic or mixed episodes associated
with bipolar I disorder in adults and the treatment of
schizophrenia in adults. More than 500,000 prescriptions have been
written by more than 20,000 prescribers who have treated more than
100,000 patients with VRAYLAR.
About VRAYLAR® (cariprazine)
VRAYLAR is an oral, once daily atypical antipsychotic approved
for the acute treatment of adult patients with manic or mixed
episodes associated with bipolar I disorder, with a recommended
dose range of 3 to 6 mg/day, and for the treatment of schizophrenia
in adults, with a recommended dose range of 1.5 to 6 mg/day.
While the mechanism of action of VRAYLAR is unknown, the
efficacy of VRAYLAR could be mediated through a combination of
partial agonist activity at central dopamine D₂ and serotonin
5-HT1A receptors and antagonist activity at
serotonin 5-HT2A receptors. Pharmacodynamic studies
with cariprazine have shown that it acts as a partial agonist with
high binding affinity at dopamine D3, dopamine
D2, and serotonin 5-HT1A receptors.
Cariprazine demonstrated up to ~8-fold greater in
vitro affinity for dopamine D3 vs
D2 receptors. Cariprazine also acts as an
antagonist at serotonin 5-HT2B and
5-HT2A receptors with high and moderate binding
affinity, respectively as well as it binds to the histamine
H1 receptors.
Cariprazine shows lower binding affinity to the serotonin
5-HT2C and α1A- adrenergic receptors and
has no appreciable affinity for cholinergic muscarinic receptors.
The clinical significance of these in vitro data
is unknown.
VRAYLAR was discovered and co-developed by Gedeon Richter
Plc and is licensed by Allergan, in the U.S.
and Canada. For more than a decade both companies have
conducted over 20 clinical trials enrolling thousands of
patients worldwide to evaluate the efficacy and safety of
cariprazine for people living with a broad range of mental health
illnesses.
Visit www.vraylar.com for more information.
INDICATION AND USAGE
VRAYLAR (cariprazine) is
indicated in adults for the treatment of schizophrenia and for the
acute treatment of manic or mixed episodes of bipolar I
disorder.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED
MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
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Elderly patients
with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. VRAYLAR is not approved for
treatment of patients with dementia-related
psychosis.
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Contraindication: VRAYLAR is contraindicated in patients
with known hypersensitivity. Reactions have included rash,
pruritus, urticaria, and events suggestive of angioedema.
Cerebrovascular Adverse Reactions, Including Stroke: In
clinical trials with antipsychotic drugs, elderly subjects with
dementia had a higher incidence of cerebrovascular adverse
reactions, including fatalities vs placebo. VRAYLAR is not approved
for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially
fatal symptom complex, has been reported with antipsychotic drugs.
NMS may cause hyperpyrexia, muscle rigidity, delirium, and
autonomic instability. Additional signs may include elevated
creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute
renal failure. Manage with immediate discontinuation,
intensive symptomatic treatment, and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a
syndrome of potentially irreversible, involuntary, dyskinetic
movements) and the likelihood it will become irreversible may
increase with the duration of treatment and the cumulative dose.
The syndrome can develop after a relatively brief treatment period,
even at low doses, or after treatment discontinuation. If signs and
symptoms of TD appear, drug discontinuation should be
considered.
Late-Occurring Adverse Reactions: Adverse events may
first appear several weeks after initiation of VRAYLAR, probably
because plasma levels of cariprazine and its major metabolites
accumulate over time. As a result, the incidence of adverse
reactions in short-term trials may not reflect the rates after
longer term exposures. Monitor for adverse reactions, including
extrapyramidal symptoms (EPS) or akathisia, and patient response
for several weeks after starting VRAYLAR and after each dosage
increase. Consider reducing the dose or discontinuing the drug.
Metabolic Changes: Atypical antipsychotics have caused
metabolic changes, such as:
- Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in
some cases associated with ketoacidosis, hyperosmolar coma, or
death, has been reported in patients treated with atypical
antipsychotics. Assess fasting glucose before or soon after
initiation of treatment, and monitor periodically during long-term
treatment.
- Dyslipidemia: Atypical antipsychotics cause adverse
alterations in lipids. Before or soon after starting an
antipsychotic, obtain baseline fasting lipid profile and monitor
periodically during treatment.
- Weight Gain: Weight gain has been observed with VRAYLAR.
Monitor weight at baseline and frequently thereafter.
Leukopenia, Neutropenia, and Agranulocytosis:
Leukopenia/neutropenia have been reported with antipsychotics,
including VRAYLAR. Agranulocytosis (including fatal cases) has been
reported with other antipsychotics. Monitor complete blood count in
patients with pre-existing low white blood cell count
(WBC)/absolute neutrophil count or history of drug-induced
leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a
clinically significant decline in WBC and in severely neutropenic
patients.
Orthostatic Hypotension and Syncope: Atypical
antipsychotics cause orthostatic hypotension and syncope, with the
greatest risk during initial titration and with dose increases.
Monitor orthostatic vital signs in patients predisposed to
hypotension and in those with cardiovascular/cerebrovascular
diseases.
Falls: VRAYLAR may cause somnolence, postural
hypotension, motor and sensory instability, which may lead to falls
and, consequently, fractures, or other injuries. For patients with
diseases, conditions, or medications that could exacerbate these
effects, complete fall risk assessments when initiating
antipsychotics and recurrently for patients on long-term
therapy.
Seizures: Use VRAYLAR with caution in patients with
history of seizures or with conditions that lower the seizure
threshold.
Potential for Cognitive and Motor Impairment: Somnolence
was reported with VRAYLAR. Caution patients about performing
activities requiring mental alertness (eg, operating hazardous
machinery or a motor vehicle).
Body Temperature Dysregulation: Use VRAYLAR with caution
in patients who may experience conditions that increase body
temperature (eg, strenuous exercise, extreme heat, dehydration, or
concomitant anticholinergics).
Dysphagia: Esophageal dysmotility and aspiration have
been associated with antipsychotics. Antipsychotic drugs, including
VRAYLAR, should be used cautiously in patients at risk for
aspiration.
Drug Interactions: Strong CYP3A4 inhibitors increase
VRAYLAR concentrations, so VRAYLAR dose reduction is recommended.
Concomitant use with CYP3A4 inducers is not recommended.
Adverse Reactions: In clinical trials, the most common
adverse reactions (≥5% and at least twice the rate of placebo) are
listed below:
- Schizophrenia: The incidences within the recommended dose range
(VRAYLAR 1.5 – 3 mg/day and 4.5 – 6 mg/day vs placebo) were: EPS
(15%, 19% vs 8%) and akathisia (9%, 13% vs 4%)
- Bipolar mania: The incidences within the recommended dose range
(VRAYLAR 3 – 6 mg/day vs placebo) were: EPS (26% vs 12%), akathisia
(20% vs 5%), dyspepsia (7% vs 4%), vomiting (10% vs 4%), somnolence
(7% vs 4%), and restlessness (7% vs 2%)
Please also see full Prescribing Information,
including Boxed Warning.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
CONTACTS:
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Allergan:
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Investors:
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Manisha Narasimhan,
PhD
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(862)
261-7162
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Media:
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Amy Rose
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(862)
289-3072
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Julie
Ciardiello
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(732)
429-4909
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SOURCE Allergan plc