Navigation Links
Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
Date:5/15/2012

EMERYVILLE, Calif., May 15, 2012 /PRNewswire/ -- Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has held an End-of-Phase 2 meeting with the FDA to discuss the proposed safety and efficacy studies to be conducted for the registration of Arimenda (memantine HCl extended release and donepezil HCl) capsules. Arimenda, a once-daily fixed dose combination of extended release memantine and donepezil, is being developed for the treatment of moderate-to-severe Alzheimer's dementia. At the meeting, the FDA agreed to Adamas' Phase 3 clinical safety studies and confirmed that, if successful, those studies should be sufficient to support a future NDA submission. Adamas is on track to submit its first NDA for Arimenda in 2013.

"This development milestone enables Adamas to initiate a pivotal safety study of Arimenda in Alzheimer's patients for whom a fixed dose combination drug therapy would provide clinical benefit and optimal administration," said Gregory T. Went, Ph.D., Chief Executive Officer of Adamas. "NDA-enabling manufacturing activities with our CMO partners are now underway, and we look forward to commencing Arimenda pivotal studies shortly." 

About Arimenda (ADS-8704)

Arimenda (memantine HCl ER and donepezil HCl) capsules are expected to be the first once-daily fixed dose combination product for Alzheimer's disease available for the US market.  Arimenda is designed to simplify the initiation of combination therapy by providing the most convenient means to introduce combination therapy to patients who are already taking donepezil.  Arimenda's improved release profile will result in a simplified, once-daily, one-step titration product, overcoming poor compliance by patients who are challenged by having to take 3 pills per day.  In addition, unlike the currently marketed products, it will permit caregivers to sprinkle the contents of the drug onto food for patients who have
'/>"/>

SOURCE Adamas Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Adamas Pharmaceuticals Signs CRADA With U.S. Navy to Conduct Preclinical Studies of Triple-Combination Antiviral Drug Therapy for Influenza A, Including the Novel H1N1 Pandemic Strain
2. In Vitro Study of Adamas Pharmaceuticals Triple Combination Antiviral Drug Therapy Shows Activity Against Drug-Resistant Influenza Viruses
3. Adamas Pharmaceuticals Announces In Vitro Data Demonstrating TCAD Therapy is More Potent Than Double Combinations or Monotherapy Against Drug-Resistant Flu Strains
4. Adamas Pharmaceuticals TCAD Therapy Demonstrates Broad Spectrum Activity Against Susceptible and Resistant Strains of Influenza in Animal Models
5. Adamas Pharmaceuticals Initiates a Phase 2/3 Clinical Study of ADS-5102 for Parkinsons Disease
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
9. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
10. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
11. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... Aug. 27, 2014  Decision Resources Group finds ... oncology, hematology-oncology, rheumatology, gastroenterology, endocrinology and nephrology) expect ... a biosimilar has been assessed in to be ... choose to prescribe. Other key ... Acceptance of Biosimilars Across Physician Specialties ...
(Date:8/27/2014)... Fla. , Aug. 27, 2014 ... today that it has released a preview of its ... the pharmaceutical industry avoid drug shortages and maintain a ... The Plan, a first for the ... and biopharmaceutical industry members and describes how industry can ...
(Date:8/27/2014)... YORK , Aug. 27, 2014 Reportlinker.com ... in its catalogue: Baby Food Eastern Europe ... Summary "Baby Food Eastern Europe 2014" is a new ... demand prospects in Eastern Europe , ... various trends. This report also examines trends which are ...
Breaking Medicine Technology:Surveyed Physicians Expect to Choose Between Future Biosimilars Based on Robustness and Number of Clinical Trials 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 3ISPE Releases First Look at its Plan to Prevent Drug Shortages 4Baby Food Eastern Europe 2014 2Baby Food Eastern Europe 2014 3Baby Food Eastern Europe 2014 4Baby Food Eastern Europe 2014 5Baby Food Eastern Europe 2014 6Baby Food Eastern Europe 2014 7Baby Food Eastern Europe 2014 8
(Date:8/27/2014)... 28, 2014 The National League for ... DrPH, MN, RN, FAAN, became the inaugural director of ... Advancement of the Science of Nursing Education , effective ... comprise the NLN Home for Transformative Excellence, established with ... year ago. , Under Dr. Dennis’s leadership, the ...
(Date:8/27/2014)... August 28, 2014 Recently, Skmen.com, a ... designs of celebrity bodycon dresses . The company ... has thousands of trendy items in stock and ready ... casual outfits, long sleeve sweater dresses and so forth. ... stunning colours. , “We are proud to announce ...
(Date:8/27/2014)... 2014 Philadelphia, PA. Inc. magazine ... Inc. 500 list, an exclusive ranking of the nation’s ... comprehensive look at the most important segment of the ... gained early exposure as members of the Inc. 500 ... , “Some of world’s greatest companies have had ...
(Date:8/27/2014)... All Canada Goose Parkas from ... from classic to modern. With unique detailing such as buttons, ... is a step up in opulence. Recently, the company has ... for 2014. , True enough, the new assortment ... discounts (up to 28% off) on all these brand new ...
(Date:8/27/2014)... Locating an approximate price for an insurance ... information before rates would be viewable. The Quotes Pros ... are distributed online using its policy locator at ... adult has access to review using the national finder ... for quotation distribution built in 2013 is now programmed ...
Breaking Medicine News(10 mins):Health News:Betty Pierce Dennis to Lead NLN/Chamberlain College of Nursing Center for the Advancement of the Science of Nursing Education 2Health News:Betty Pierce Dennis to Lead NLN/Chamberlain College of Nursing Center for the Advancement of the Science of Nursing Education 3Health News:Betty Pierce Dennis to Lead NLN/Chamberlain College of Nursing Center for the Advancement of the Science of Nursing Education 4Health News:Skmen.com Unveils Its New Celebrity Bodycon Dresses for Its Loyal Customers 2Health News:Inc Magazine Unveils 33rd Annual List of America's Fastest-Growing Private Companies - the Inc. 500 2Health News:CanadaGooseJackor.nu: 2014 Canada Goose Banff Parkas At Discounted Prices 2Health News:Life Insurance Quotes for Term Policies Now Found at Insurer Website Online 2
... more likely than others to introduce their infants to cow,s ... children at risk of health complications, according to a study ... and Poverty, New York. The study showed that women ... during their first or second trimester of pregnancy -- from ...
... Steven Reinberg HealthDay Reporter , MONDAY, June 28 ... cholesterol levels, statins don,t appear to reduce the chances of ... scientists have found. Statins are used widely to treat ... with heart disease and -- in more recent years -- ...
... ... California based laboratory equipment repair and instrument calibration services company, has been formally ... calibration lab., , ... (PRWEB) June 29, 2010 -- Beginning in 2009, the AL-TAR Quality ...
... Advanced ... percutaneous—or through the skin—techniques, according to a new study appearing online and in the ... ... 2010 -- Advanced imaging technologies have helped shift biopsy techniques away from more invasive ...
... Advanced imaging technologies have helped shift biopsy techniques away ... skintechniques, according to a new study appearing online and ... Radiology . Biopsythe removal of cells or ... The first percutaneous needle biopsy of the liver was ...
... A literature review, led by Dr. Joseph Lee, published in the ... Academy of Orthopaedic Surgeons ( JAAOS ) suggests that a ... back and leg pain in adults, but surgery is not for ... low back pain at some point in their lives Disks, ...
Cached Medicine News:Health News:WIC might prevent mothers from feeding cow's milk too early 2Health News:Statins May Not Be as Helpful for Those Without Heart Disease 2Health News:Statins May Not Be as Helpful for Those Without Heart Disease 3Health News:AL-TAR Services, Inc. Laboratory Is Now Accredited For ACLASS Standards 2Health News:Use of Less Invasive, Imaging-Guided Biopsies on the Rise 2Health News:Use of Less Invasive, Imaging-Guided Biopsies on the Rise 3Health News:Use of less invasive, imaging-guided biopsies on the rise 2Health News:Lower back pain and surgery 2
... concave seats and standard-sized backrests with ... seats, backrests, armrests, and casters and ... for the following environments: industry, education, ... care and office. • With polished ...
... Basic ergonomic chairs with concave ... support • Select options like seats, ... • BTN/1Q-CAB chairs are recommended for ... clean room, static control, health care ...
... Basic ergonomic chairs with concave ... support • Select options like seats, ... • BTN/1Q-CAB chairs are recommended for ... clean room, static control, health care ...
... chairs with concave seats and standard-sized ... options like seats, backrests, armrests, and ... are recommended for the following environments: ... control, health care and office. • ...
Medicine Products: