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 difficulty swallowing.  By providing a once-daily regimen for patients with moderate to severe Alzheimer's disease, Arimenda will meet the market need for a therapy that has the potential to ease caregiver burden, extend the duration of homecare, and delay the admission of patients to costly skilled nursing facilities.  Arimenda will be investigated in a Phase 3 safety study of up to 300 subjects to be conducted at approximately 50 centers in the United States and rest of the world. 

About Alzheimer's Disease

Alzheimer's disease is a chronic, progressive neurodegenerative condition that afflicts over 50 million patients worldwide including more than 5 million sufferers in the United States. The direct healthcare costs exceed $200 billion driven by moderate to severe patients who require care in nursing facilities and assisted living facility.  Caregiver burden is a second significant economic cost of the disease with 15 million caregivers providing 17 billion hours of unpaid care to dementia patients per year, valued at over $200 billion. The treated population is forecast to increase from the current 2.2 million to nearly 3.5 million by 2020.  

There is no cure on the horizon for Alzheimer's disease or for other diseases that cause dementia. Progression of dementia leads to dependence on caregivers and family, who struggle with managing activities of daily living, behavioral challenges, and complicated dosing regimens of the multiple medications that most dementia patients require. Recent outcome studies have shown that memantine and donepezil combination therapy, as compared to monotherapy, significantly increases the time nursing home admissions and significantly reduces health care costs. Despite these benefits, less than 30% of patients are currently treated with combination therapy. Adamas' Arimenda is specifically designed to address these issues, increasing the access to combination therapy and reducing overall health costs. 

About Adamas

Adamas Pharmaceuticals, based in Emeryville, California with operations in Bangalore, India, is the leading developer of aminoadamantane-based therapeutics for CNS disorders. The Company's research and development platform is focused on developing controlled release versions and optimized fixed dose combinations of aminoadamantanes to address dosing and titration challenges that limit the use of currently available products. Adamas is advancing two programs through Phase 3 clinical studies, including Arimenda (memantine HCl extended release and donepezil HCl) capsules for Alzheimer's disease, and Nurelin™, ADS-5102 (amantadine HCl extended release) capsules, initially for levodopa-induced dyskinesia in patients with Parkinson's disease. Both products are designed to improve tolerability and clinical efficacy, and to provide superior clinical and health economic benefits. For more information about Adamas, please visit www.adamaspharma.com.


'/>"/>
SOURCE Adamas Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
(Date:10/7/2017)... Texas , Oct. 6, 2017   Provista, ... with more than $100 billion in purchasing power, today ... news and information. The Newsroom is the ... and industry trends, infographics, expert bios, news releases, slideshows ... having access to a wealth of resources at their ...
(Date:10/4/2017)...  South Korean-based healthcare product Development Company I.M. Lab ... Kickstarter. The device will educate the user about ,proper, ... efficiency compared to the dated and pricey CPR training ... of the compression for a more informed CPR training. ... raise $5,000. cprCUBE ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... Lori R. Somekh, founder of the Law Office of Somekh ... law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain up ... network with elder law attorneys nationwide,” said Somekh. , ElderCounsel was ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) ... FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... Morris F. Collen, a pioneer in the field of medical informatics, this prestigious award ...
Breaking Medicine News(10 mins):