DUBLIN and BUDAPEST, Hungary, May
12, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon
Richter Plc. today announced that nine posters highlighting
additional scientific data and clinical research on cariprazine, an
atypical antipsychotic, will be presented during the upcoming
American Psychiatric Association Annual Meeting in Atlanta, GA, May 14 to
May 18, 2016.
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"Advancing scientific discovery and addressing unmet clinical
needs are at the heart of Allergan's Open Science approach," said
Dr. David Nicholson, President &
Executive Vice President, Global R&D at Allergan. "The
abstracts presented at APA underscore the safety and efficacy of
cariprazine, and investigated its potential to provide additional
therapeutic benefits for the treatment of bipolar depression and
the negative symptoms of schizophrenia."
The titles of the poster presentations are as follows:
Monday, May 16, 2016, 2:00-4:00 p.m. ET
- Relationship of Cariprazine Plasma Concentration to Efficacy
and Safety in Patients with Schizophrenia or Bipolar Mania
(P6-014), authored by Carrothers, T., Willavize, S., Jaworowicz,
D., Passarell, J., Periclou, A., Ghahramani, P., Durgam, S.,
Earley, W., Kapás, M., Khariton, T.
Tuesday, May 17, 2016,
2:00-4:00 p.m. ET
- Efficacy of Cariprazine on Predominant Negative Symptoms of
Patients with Schizophrenia: Post Hoc Analysis of PANSS data,
Marder Factors and Cognition (P8-081), authored by Marder, S.,
Laszlovszky, I., Szalai, E., Szatmári, B., Harsányi, J., Barabássy,
A., Debelle, M., Durgam, S., Bitter, I., Németh, G.
- Efficacy of Cariprazine in Negative, Cognitive, and Social
Function Symptoms in Schizophrenia: Post Hoc Analysis of a
Randomized, Controlled Trial (P8-022), authored by Cutler, A.,
Durgam, S., Lu, K., Laszlovszky, I., Earley, W.
- Early Improvement is a Predictor of Response and Remission
in Bipolar I Disorder: A Pooled Analysis of 3 Randomized
Cariprazine Trials (P8-026), authored by Durgam, S.,
Calabrese, J., Earley, W., Migliore, R., Lu, K., Laszlovszky,
I.
- Safety and Efficacy of Cariprazine in FDA-Approved Dose
Ranges for Schizophrenia and Bipolar I Disorder: A Pooled Post Hoc
Analysis (P8-027), authored by Earley, W., Durgam, S., Lu, K.,
Németh, G., Laszlovszky, I.
- Long-Term Cariprazine Treatment for the Prevention of
Relapse in Patients With Schizophrenia: Analysis of Additional
Efficacy Outcomes (P8-095), authored by Nasrallah, H., Durgam,
S., Earley, W., Lu, K., Laszlovszky, I.
- Efficacy of Cariprazine in Bipolar Depression: Post Hoc
Band-Pass Analyses of 2 Randomized, Double-Blind,
Placebo-Controlled Trials (P8-144), authored by Yatham, L.,
Vieta, E., Durgam, S., Earley, W., Lu, K., Laszlovszky, I.
- Pharmacological Characteristics of Major Human Metabolites
of Cariprazine (P8-062), authored by Kiss, B., Némethy, Z.,
Laszlovszky, I., Gyertyán, I., Adham N.
- Characterization of Population Pharmacokinetics of
Cariprazine and Its Major Metabolites (P8-105), authored by
Periclou, A., Phillips, L., Bihorel, S., Ghahramani, P., Kapás, M.,
Carrothers, T., Khariton, T.
About Cariprazine
Cariprazine 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.
Cariprazine – marketed as VRAYLAR™ in the United States – was approved by the U.S.
Food and Drug Administration for the treatment of acute manic or
mixed episodes of bipolar I disorder and schizophrenia in
adults.
Although the exact mechanism of action for cariprazine is
unknown, it is thought to affect the activity of neurotransmitters
such as dopamine and serotonin. The efficacy of cariprazine 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 have shown that VRAYLAR (cariprazine)
acts as a partial agonist at the dopamine D3 and
dopamine D2 receptors, with high binding affinity
(Ki values of 0.085 nM, and 0.49 nM
(D2L) and 0.69 nM (D2S), respectively).
Cariprazine demonstrated up to
~8-fold greater in vitro affinity for dopamine
D3 vs D2 receptors. Cariprazine acts as a
partial agonist at serotonin 5-HT1A receptors
(Ki value of 2.6 nM) and as an antagonist at serotonin
5-HT2B and 5-HT2A receptors with high and
moderate binding affinity (Ki values of 0.58 nM and 18.8
nM, respectively). It also binds to the histamine H1
receptors (Ki value of 23.2 nM). Cariprazine shows lower
binding affinity for the serotonin 5-HT2C and
α1A-adrenergic receptors (Ki values of 134 nM
and155 nM, respectively) and has no appreciable affinity for
cholinergic muscarinic receptors (IC50>1000 nM). The
clinical significance of these in vitro data is unknown.
Cariprazine was discovered and co-developed by Gedeon Richter
Plc and is licensed to Allergan in the U.S. and Canada.
Visit www.VRAYLAR.com for more information on this once daily
option for the acute treatment of manic or mixed episodes
associated with bipolar I disorder and for the treatment of
schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
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.
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 antipsychotics 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.
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, at www.vraylar.com.
About Gedeon Richter
Gedeon Richter Plc. (www.richter.hu), headquartered in
Budapest/Hungary, is a major
pharmaceutical company in Central Eastern Europe, with an expanding
direct presence in Western Europe.
Having reached a market capitalisation of EUR 3.3 billion (US$ 3.6
billion) by the end of 2015, Richter's consolidated sales
were approximately EUR 1.2 billion
(US$ 1.3 billion) during the same
year. The product portfolio of Richter covers many important
therapeutic areas, including gynaecology, central nervous system,
and cardiovascular areas. Having the largest R&D unit in
Central Eastern Europe, Richter's original research activity
focuses on CNS disorders. With its widely acknowledged steroid
chemistry expertise, Richter is a significant player in the female
healthcare field worldwide. Richter is also active in biosimilar
product development.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing, manufacturing and
commercializing innovative branded pharmaceuticals, high-quality
generic and over-the-counter medicines and biologic products for
patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations 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.
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 of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. 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 risks associated with acquisition
transactions; 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; 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 Quarterly Report on Form
10-Q for the quarter ended December 31,
2015 (such periodic public filings having been filed under
the "Actavis plc" name) and from time to time in Allergan's other
investor communications . Except as expressly required by law,
Allergan disclaims any intent or obligation to update these
forward-looking statements.
ALLERGAN CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
GEDEON RICHTER CONTACTS:
Investors:
Katalin Ördög
+36 1 431 5680
Media:
Zsuzsa Beke
+36 1 431 4888
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SOURCE Allergan plc