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:7/31/2014)... July 31, 2014  Decision Resources Group,s ... about by the Affordable Care Act (ACA), ... of pharmaceutical therapies. The ACA altered how ... new regulations and expanded access via government-supported ... health exchanges—state-based marketplaces set up by states ...
(Date:7/31/2014)... Hovione today announced that its API ... passed a pre-approval inspection by the US Food and Drug ... FDA Consumer Safety Officer, Ms. Britanny Terhar , lasted ... July and concluded on the 25 th . The inspection ... guidelines of Good Manufacturing Practices (GMP) and no Form 483 ...
(Date:7/31/2014)... announces the list of stocks featured in the Analyst Blog. ... news and events impacting stocks and the financial markets. Stocks ... - Free Report ), Gilead (Nasdaq: GILD - Free ... ), AbbVie (NYSE: ABBV - Free Report ) and ... Today, Zacks is promoting its ,Buy, stock recommendations. Get ...
Breaking Medicine Technology:Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 2Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 3Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 4Successful FDA Inspection at Hovione's API Manufacturing Plant in Cork, Ireland 2The Zacks Analyst Blog Highlights: Biogen, Gilead, Puma Biotechnology, AbbVie and Celgene 2The Zacks Analyst Blog Highlights: Biogen, Gilead, Puma Biotechnology, AbbVie and Celgene 3The Zacks Analyst Blog Highlights: Biogen, Gilead, Puma Biotechnology, AbbVie and Celgene 4The Zacks Analyst Blog Highlights: Biogen, Gilead, Puma Biotechnology, AbbVie and Celgene 5The Zacks Analyst Blog Highlights: Biogen, Gilead, Puma Biotechnology, AbbVie and Celgene 6
... MADISON, N.J. and AUSTIN, Texas, May 24, 2011 ... Obstetrics & Gynecology demonstrated that adding OVA1 to ... would identify more ovarian cancers than a physician,s preoperative ... this month in the journal, which is the official ...
... May 24, 2011 The Board of Directors of BD (Becton, ... quarterly dividend of 41 cents per common share, payable on June ... indicated annual dividend rate is $1.64 per share. ... leading global medical technology company that develops, manufactures and sells medical ...
Cached Medicine Technology:OVA1 Improves Ovarian Cancer Detection Over CA 125 Blood Test and Clinical Assessment 2OVA1 Improves Ovarian Cancer Detection Over CA 125 Blood Test and Clinical Assessment 3OVA1 Improves Ovarian Cancer Detection Over CA 125 Blood Test and Clinical Assessment 4
(Date:8/1/2014)... Fitness is something most people can add ... around the block to biking ten or more miles, adding ... maintain throughout the year. The Forbes Living talk show ... will feature special guests, tips to get started and cool ... series will air on most popular cable television networks. ...
(Date:8/1/2014)... Online retailer Disposable Medical Express has ... guarantee on their inventory of Tranquility incontinence care products. ... pads along with other personal care products. , ... a line of incontinence products that you love,” a ... works for you, you shouldn't have to compromise because ...
(Date:8/1/2014)... 01, 2014 We are very ... on AWS Marketplace. EspressReport ES-AMI delivers enterprise grade ... $0.50 per hour (AWS infrastructure charges apply). , ... enterprise BI and operational reporting system with strong ... ad hoc reporting. It allows users to easily ...
(Date:8/1/2014)... Stress management can be difficult in this day and ... diminish rest and leisure time, stress can mount up and ... a way to manage stress in order to be healthy ... good sense of work-life balance is the key to managing ... of SF Custom Chiropractic. “Stress, left unchecked, can not only ...
(Date:8/1/2014)... US (PRWEB) August 01, 2014 Register to ... one of the most active years on record for life ... in life sciences represented 22 percent of all venture dollars ... exits and achieved high valuations. , However, 2014 is ... a recent report by Silicon Valley Bank, while life sciences ...
Breaking Medicine News(10 mins):Health News:Forbes Living to Air Fitness Forward Series 2Health News:Disposable Medical Express Offering Low Price Guarantee On Tranquility Products 2Health News:Quadbase Systems Inc. Announces The Availability Of It’s Flagship Enterprise Reporting, Dashboard and BI Analytics Tool on Amazon’s AWS Marketplace 2Health News:SF Custom Chiropractic Celebrates National Relaxation Day and the Benefits of Massage Therapy for the Month of August 2Health News:Register to Join the Merrill DataSite's Webinar - Built to Sell: The Life Sciences Deal Climate 2Health News:Register to Join the Merrill DataSite's Webinar - Built to Sell: The Life Sciences Deal Climate 3
... the Prime Minister, Premiers and Chief Ministers urging the ... and childcare workers are trained in recognizing and handling ... COAG also should ensure the provision of legal immunity ... severe allergic reactions. ,'Greater awareness and ...
... says that Tai Chi, may be helpful in preventing ... been found not only to increase// the immunity to ... to varicella vaccine as well. ,This National ... clinical trial to suggest that a behavioral intervention, alone ...
... in Mumbai will soon start an integrated trauma care facility ... to patients on way to a hospital from an accident ... Physicians of Indian Origin (AAPI), the emergency medical service and ... within minutes of an accident. ,"The ambulance would ...
... Radiologists using computer-aided detection software for mammograms are more ... than "human reviewers using// their eyes and experience," and ... to a study. ,CAD systems use complex ... a radiologist to review. The systems, which cost $50,000 ...
... - supporting research and providing education, advocacy and ... - today said physicians should consider lowering the ... with multiple myeloma. ,High dose dexamethasone ... treatment of myeloma alone and in combination with ...
... McGill University in Montreal in Canada have found that by ... alter the speed with which the mice// learned to perform ... develop drugs to improve memory. ,The finding paves ... loss and dementia, but similar drugs might also improve the ...
Cached Medicine News:Health News:COAG Must Make Combating Severe Allergies A National Priority 2Health News:Tai Chi may Be Useful to Prevent Shingles in Older Adults 2Health News:Mumbai to Have Integrated Trauma Care Facility 2Health News:Mumbai to Have Integrated Trauma Care Facility 3Health News:New Clinical Trial Results Could Improve Survival for Myeloma Patients 2Health News:New Clinical Trial Results Could Improve Survival for Myeloma Patients 3Health News:Canadian Researchers Raise Hopes of Treatment for Memory Loss 2
... Insulin-like growth factor binding protein-3 (IGFBP-3) is the ... postnatal serum, as a component of the ~150 ... a molecule of IGF-I or IGF-II and ALS, ... actions of the IGFs. The molar concentration of ...
... Growth hormone (GH) is a monomeric protein ... anterior pituitary gland. GH is released from ... pulsatile manner under the regulatory control of ... [1]. The timing and frequency of GH ...
... hormone (GH) is a monomeric protein produced ... pituitary gland. GH is released from the ... manner under the regulatory control of hypothalamic ... The timing and frequency of GH release ...
... (IGF-I or somatomedin C) is a 7.6 kDa ... as a potent mitogen of cellular proliferation, exerting ... In the circulation, IGF-I is bound to IGF-binding ... of IGF-I by modulating the interaction of IGF-I ...
Medicine Products: