DUBLIN and BUDAPEST, Hungary, Dec. 4, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced they will present data on VRAYLAR (cariprazine) in patients with schizophrenia during the 54th American College of Neuropsychopharmacology (ACNP) Annual Meeting in Hollywood Florida, to be held December 6 10, 2015.
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Data to be presented include additional analyses of cariprazine for the potential treatment of predominant negative symptoms in patients with schizophrenia. Also presented will be data investigating the metabolic safety profile of cariprazine and its impact on long-term schizophrenia relapse prevention.
Data Blitz oral presentation given by Rene Kahn
Monday, December 7, 2015, 11:30 a.m.-1:30 p.m. ET, Oral Presentation
- Cariprazine as Monotherapy for the Treatment of Predominant Negative Symptoms of Patients with Schizophrenia: A Double-Blind, Active Comparator-Controlled Trial (poster M206) authored by Debelle, M., Nemeth, G., Szalai, E., Szatmari, B., Harsanyi, J., Barabassy, A., Laszlovszky, I., Durgam, S., Fleischhacker, W.W., Kahn, R.
Posters
Monday, December 7, 2015, 5:30-7:30 p.m. ET
- Cariprazine as Monotherapy for the Treatment of Predominant Negative Symptoms of Patients with Schizophrenia: A Double-Blind, Active Comparator-Controlled Trial (poster M206) authored by Debelle, M., Nemeth, G., Szalai, E., Szatmari, B., Harsanyi, J., Barabassy, A., Laszlovszky, I., Durgam, S., Fleischhacker, W.W., Kahn, R.
- Cariprazine for Negative Symptoms of Schizophrenia: Pooled Post Hoc Analysis of 2 Randomized, Double-Blind, Placebo- and Active-Controlled Trials (poster M204), authored by Earley, W., Durgam, S., Debelle, M., Laszlovszky, I., Lu, K., Nasrallah, H.
- Metabolic Safety of Cariprazine in Patients with Schizophrenia (poster M156) authored by Marder, S., Zukin, S., Lu, K., Debelle, M., Durgam, S.
Tuesday, December 8, 2015, 5:30-7:30 p.m. ET
Long-Term Cariprazine Treatment for the Prevention of Relapse in Patients With Schizophrenia: Additional Analysis From a Randomized, Double-Blind, Placebo-Controlled Trial (poster T170), authored by Durgam, S., Earley, W., Li, R., Li, D., Lu, K., Laszlovszky, I., Edwards, J., Nasrallah, H., Fleischhacker, W.W.
About VRAYLAR TM(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. The safety and efficacy of VRAYLAR was studied in a clinical trial program of more than 2,700 patients with these conditions.
Vraylar acts as a partial agonist at the dopamine D3 and D2 receptors. At antipsychotic doses, Vraylar shows high brain occupancy of both D3 and D2 receptors in schizophrenia patients. Vraylar is also a high affinity partial agonist at serotonin 5-HT1A receptors. In addition, Vraylar acts as an antagonist with high affinity at 5-HT2B receptors and moderate affinity at 5-HT2A and histamine H1 receptors . Vraylar shows lower binding affinity to the serotonin 5-HT2C and 1A- adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors.
VRAYLAR was discovered and co-developed by Gedeon Richter Plc and is licensed to Actavis, now Allergan, in the U.S. and Canada.
Cariprazine is also being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
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 |
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. Monitor for adverse reactions 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. Dose-related increase in certain adverse reactions was observed, particularly above the maximum recommended dose of 6 mg/day.
- Schizophrenia: The incidences within the recommended dose range (VRAYLAR 1.5 3 mg/day and 4.5 6 mg/day vs placebo) were: extrapyramidal symptoms (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: extrapyramidal symptoms (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 the full Prescribing Information, including Boxed Warning at www.VRYALAR.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. Richter’s consolidated sales were approximately EUR 1.1 billion (US$ 1.5 billion), while its market capitalization amounted to EUR 2.1 billion (US$ 2.5 billion) in 2014. The product portfolio of Richter covers almost all 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 March 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 Ordog
+36 1 431 5680
Media:
Zsuzsa Beke
+36 1 431 4888
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SOURCE Allergan plc
