Navigation Links
New Data Highlights Positive Results of Namenda (Memantine HCl) Once-Daily Extended-Release Formulation
Date:7/30/2008

Results Presented at ICAD 2008 Highlight Significant Improvement in Cognitive Performance and Global Clinical Status in Patients with Alzheimer's Disease

Chicago, IL (PRWEB) July 30, 2008 -- www.frx.com [Forest Laboratories, Inc.] (NYSE: FRX) presented today positive Phase III data of a once-daily extended-release formulation of Namenda® (memantine HCl) at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD). The study evaluated the efficacy, safety and tolerability of an innovative, proprietary, 28 mg once-daily extended-release formulation of Namenda compared to placebo in outpatients with moderate to severe Alzheimer's disease already being treated with a cholinesterase inhibitor (donepezil, galantamine or rivastigmine).

In the study, patients treated with once-daily extended-release Namenda experienced significant improvements in cognitive performance and global clinical status compared to those receiving placebo. Patients treated with once-daily extended-release Namenda also experienced significant improvements in verbal fluency and behavioral symptoms as compared to placebo. The results build on preliminary findings announced by Forest in February.

"While there is no cure or existing treatment to prevent Alzheimer's disease, there are currently- available FDA-approved treatments, such as combination therapy with memantine and a cholinesterase inhibitor, which can alleviate symptoms by providing cognitive, functional, and behavioral benefits," said George Grossberg, MD, Director of Geriatric Psychiatry at Saint Louis University School of Medicine, and the lead investigator who presented the data. "These findings reinforce the safety, tolerability and efficacy of memantine in a newly-developed once-a-day formulation."

Marco Taglietti, MD, Executive Vice President and Chief Medical Officer at Forest added, "With this novel formulation, the efficacy and tolerability of Namenda is delivered in a more convenient, once-daily dose."

About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor was conducted in multiple centers in the United States, Argentina, Chile, and Mexico. Patients in the 24-week study were randomly assigned to receive either 28 mg/day of memantine once-daily extended-release or placebo. The primary endpoints evaluated were change from baseline on the Severe Impairment Battery (SIB) and the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) rating at week 24. The study showed statistically significantly higher cognitive abilities, as measured by the SIB, and clinical global status, as measured by the CIBIC-Plus, in patients treated with memantine 28 mg once-daily extended-release compared to placebo (p=0.001 for SIB and p=0.008 for CIBIC-Plus, both using pre-defined last observation carried forward analyses). The CIBIC-Plus is a global measure of a patient's overall status evaluating cognition, behavior, and activities of daily living.

Results for a secondary endpoint and additional assessment variables reinforced the positive findings seen with the primary endpoints. Assessments were conducted to evaluate change in behavior from baseline using the Neuropsychiatric Inventory (NPI) at 24 weeks and change in verbal fluency from baseline using the Verbal (Semantic) Fluency Test at 24 weeks. Memantine provided significant benefits over placebo (p=0.005 for NPI and p=0.004 for verbal fluency). Measurement of daily living activities using the 19-item AD Cooperative Study-Activities of Daily Living scale (ADCS-ADL) demonstrated maintenance of function during the study period, but this was not significantly different from placebo (p=0.18).

The study also demonstrated that once-daily extended-release memantine was well tolerated. The treatment-emergent AEs (TEAEs) profile was similar between the groups; no TEAEs were experienced by e 5% of memantine patients, and at an incidence at least twice that of the placebo group. The most common adverse events occurring at a higher rate than placebo were dizziness (4.7% vs 1.5%), diarrhea (5.0% vs 3.9%), and headache (5.6% vs 5.1%).

About Alzheimer's Disease
Alzheimer's disease is a progressive, degenerative disease of the brain and the most common type of dementia. Dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. By 2050, the number of individuals age 65 and over with Alzheimer's disease could range from 11 million to 16 million. Currently, all Alzheimer's disease medications approved in the US other than Namenda belong to a class of agents called cholinesterase inhibitors.

About Namenda
http://www.namenda.com [Namenda] (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, the FDA approved Namenda in October 2003 based on three studies of Namenda used alone or in combination with another Alzheimer's disease drug. At present, the recommended dose of Namenda is 10 mg two times a day (20 mg/day).

Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda vs placebo (e 5% and higher than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, dosage should be reduced.

About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a US-based pharmaceutical company with a long track record of building partnerships and developing and delivering 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 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.

###

Read the full story at http://www.prweb.com/releases/2008/07/prweb1159964.htm


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved

Related medicine news :

1. Cancer research highlights
2. Survey Highlights Physician Motivations for Working Locum Tenens Jobs
3. [video] WallSt.nets 3 Minute Press Show Features Executive Interviews and Highlights Recent Press for the Following: JSDA, GSPI, JACO, SGTI, HCPC
4. July 2008 Mayo Clinic Health Letter Highlights Bone Health, Causes of Swelling and Slimmed-Down Desserts
5. July 2008 Mayo Clinic Womens HealthSource Highlights Vitamin D, Savvy Use of Sunscreen and Gastrointestinal Upset and Celiac Disease
6. Research highlights problems of predicting birthweights in obese mothers
7. AVMA Collections Highlights Disaster Preparedness
8. Elsevier announces 2007 journal impact factor highlights
9. June 2008 Mayo Clinic Health Letter Highlights New MRI Scanning Technology, Obesity-Related Cancer, and Do-It-Yourself Massage
10. [video] WallSt.nets 3 Minute Press Show Features Executive Interviews and Highlights Recent Press for the Following: DAI, OPXA, AIRN, BCLI, GTEC and IFDG
11. [video] WallSt.nets 3 Minute Press Show Features Executive Interviews and Highlights Recent Press for the Following: IUSA, IFUE, FEED, RXEI, GMPM, CRCUF, CVSC, GNMT
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... 26, 2017 , ... Leading CEOs from biotech, pharmaceutical, and ... 31st at The Four Seasons Hotel Boston. , The Boston CEO Conference ... exclusive access to key decision makers who influence deal making and investment. Attendees ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... ... to announce a new educational seminar to focus on current legislative activity and ... seminar will begin at 1 p.m. Sunday, Sept. 10, and will continue through ...
(Date:5/26/2017)... ... ... Amir Qureshi, MD is the first physician in Arkansas to implant Nuvecta’s ... Nuvectra™ Algovita SCS System has been FDA approved as a treatment option for chronic ... introduce the most powerful SCS system and the only stretchable lead on the market. ...
(Date:5/26/2017)... Clara, Calif. (PRWEB) , ... May 26, 2017 ... ... announces the integration of the CareFusion NOX-T3 portable sleep monitor with its Somnoware ... provides a consistent, browser-based interface for diagnostic device operations. With this platform, initializing ...
(Date:5/26/2017)... MN (PRWEB) , ... May 26, 2017 , ... A ... U.S. states with the healthiest seniors are located in the Midwest. With the average ... more and more people are concerned with both the quality and affordability of where ...
Breaking Medicine News(10 mins):
(Date:5/26/2017)... , May 26, 2017  Endo International plc (NASDAQ: ... President and CEO, will represent the Company in a fireside ... Conference on Tuesday, June 13, 2017 at 10:40 a.m. PT ... Terranea Resort in Rancho Palos Verdes, CA. ... the event will be available on the Company,s website at ...
(Date:5/26/2017)... BARBARA, Calif. , May 25, 2017  In ... United States , Direct Relief is working with ... overdose-reversing Naloxone available at no cost to community health ... other nonprofit providers nationwide. "Pfizer has ... access to medicines and ensuring patient safety through educational ...
(Date:5/24/2017)... 2017  ivWatch LLC today announced the launch ... to enable seamless integration of ivWatch,s groundbreaking IV ... pumps and other devices. By integrating ivWatch technology ... help health care customers deliver a higher level ... IV therapy. "The ivWatch OEM Board ...
Breaking Medicine Technology: