Navigation Links
Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
Date:9/30/2008

NEW YORK and BUDAPEST, Hungary, Sept. 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today announced preliminary top-line results from a phase II clinical trial of cariprazine (RGH-188), an investigational antipsychotic, in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that patients with acute manic episodes treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied. Further analyses of the data will be completed in the coming weeks. Cariprazine is also currently being investigated in clinical studies in schizophrenia.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

"These exciting preliminary results in patients with bipolar mania demonstrate the potential of cariprazine as a novel antipsychotic agent," stated Marco Taglietti, M.D., Executive Vice President and Chief Medical Officer, Forest Laboratories, Inc. "Therefore, we will continue to investigate and characterize the therapeutic benefits of cariprazine, a unique molecule with high selectivity for the D3 versus the D2 dopamine receptors.

"Dopamine system stabilizer cariprazine clearly proved its effect in this study," commented Zsolt Szombathelyi, M.D., Research Director of Gedeon Richter Plc. "The result confirms Richter's CNS research concept and the clinical opportunity of a dual acting D3/D2 compound."

About the Study

The phase II double-blind, placebo-controlled, flexible-dose study evaluated the safety, efficacy and tolerability of cariprazine monotherapy in patients with acute mania associated with bipolar I disorder. During the five week study, 236 men and women 18 to 65 years of age meeting the DSM-IV criteria for bipolar I disorder were randomized and received at least one dose of either cariprazine, 3-12 mg/day (N=118), or placebo (N=118). Following a four day, no treatment wash out period, patients were given 1-4 capsules daily (cariprazine or placebo). The treatment period lasted three weeks followed by safety assessments for an additional two weeks. Patients were hospitalized throughout screening and for at least the first 14 days following the initiation of treatment.

The primary, protocol-specified, endpoint was change from baseline to Week 3 on the YMRS, using last observation carried forward (LOCF) analyses. The YMRS is a comprehensive, clinician-rated instrument used to assess the severity of mania in bipolar patients, including such parameters as elevated mood, increased motor activity energy, sleep and irritability. Statistically significant improvement was noted in patients receiving cariprazine (3-12mg/day) relative to patients receiving placebo on the YMRS scale (-15.0 cariprazine vs. -8.9 placebo, p < 0.0001) by the LOCF analysis. Statistically significant improvement in the YMRS scale was also noted in the mixed model repeated measure (MMRM) analysis (-15.5 cariprazine vs. -8.5 placebo, p < 0.0001) and the observed-cases (OC) analysis (-19.1 cariprazine vs. -13.6 placebo, p < 0.0001).

Overall premature discontinuation rates (all causes, including adverse event related) were 36 % for patients receiving cariprazine and 38% for patients receiving placebo. The most common adverse events observed in the study were headache, extrapyramidal disorders, nausea, akathisia and constipation. Cariprazine was generally well tolerated with discontinuations due to adverse events observed in 14% of the cariprazine group and 10% of the placebo group.

About Cariprazine

Cariprazine, discovered by researchers at Gedeon Richter, is an orally active, potent D3/D2 functional antagonist that preferentially binds to D3 receptors and acts as a dopamine system stabilizer. In addition, cariprazine has a low potency at other receptor sites, such as 5-HT2C, histamine H1, and adrenergic receptor sites, which have been associated with adverse events.

About Acute Mania in Bipolar Disorder

Bipolar disorder, also known as manic depression, is a serious medical illness most commonly characterized by extreme shifts in mood ranging from crippling "lows" (depression) to intense "highs" (mania).(1) During the manic phase of the illness, the person may feel euphoric or extremely irritable.(1) Other signs and symptoms include a high energy level, racing thoughts, impaired judgment, and denial that anything is wrong.(1) A manic episode is diagnosed if symptoms occur in combination most of the day, nearly every day, for one week or longer. (1)

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

About Gedeon Richter Plc.

Gedeon Richter, (http://www.richter.hu) headquartered in Budapest/Hungary, is a major pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with consolidated sales of 1.2 billion USD in 2007, and 3.4 billion USD market capitalisation. The company was founded in 1901. Gedeon Richter plays the role of a regional multinational company in Central Eastern Europe and in the CIS, and has a growing presence through its commercial subsidiaries in key EU countries, and the USA. The company has a worldwide presence through its representative offices and subsidiaries in 30 countries. It has manufacturing sites in Hungary, Russia , Romania , Poland , India and a recently acquired German R&D biotechnology production facility. The product portfolio of the company covers almost all important therapeutic areas. With its widely acknowledged steroid chemistry expertise the company is a significant player in the gynecological field worldwide. 14 % of the company's revenue results from original drug research and development activity. The company has the largest R&D unit in Central Eastern Europe focusing exclusively on the field of neurology and psychiatry. Following reorganization of the proprietary R&D in 2000, main clinical targets are schizophrenia, anxiety and chronic pain. Complementing its own preclinical excellence R&D collaboration agreements were signed with Mitsubishi Pharma Corporation (Japan) and Forest Laboratories in 2004 and 2005. The company has an original R&D portfolio with 17 ongoing projects including four compounds which are in either in Phase I or Phase II clinical trials.

References:

1. National Institute of Mental Health. "Bipolar Disorder." Available at http://www.nimh.nih.gov/health/publications/bipolar-disorder/complete- publication.shtml. Accessed: September 24, 2008.


'/>"/>
SOURCE Gedeon Richter Plc; Forest Laboratories, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
2. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
3. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
4. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
5. Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
6. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
7. Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections
8. Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference
9. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
10. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
11. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... announces the European launch of their new low volume, high throughput ... Cambridge, U.K on October 4th. The new ... unprecedented speed and sensitivity while using far less sample volume through ... ... ...
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation ... and home sensors for real-time monitoring of patients with ... nonprofit organization focused on disruptive health solutions for rare ... system to record and integrate behavioral, cognitive, physiological and ... ...
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... ... ... Planet Fitness, one of the largest and fastest growing franchisors and operators ... location in Covington, LA at 401 N. U.S. Highway 190, in January of 2018. ... in the Holiday Square shopping center. Its location allows it to serve both Covington ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... delivery system that we intend to develop to enable prevention of a major ... to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is ...
(Date:10/12/2017)... GRAND RAPIDS, Mich. (PRWEB) , ... October 12, ... ... OnSite Wellness, has been named one of Michigan’s 2017 Best and Brightest in ... Best and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 ...
Breaking Medicine News(10 mins):