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:12/22/2014)... 2014 Research and Markets ( ... "Investment Analysis of the US Medical Device ... http://photos.prnewswire.com/prnh/20130307/600769 ... device sector identifies the key trends and rationale ... and mergers and acquisitions. The study ...
(Date:12/22/2014)... STOCKHOLM , Dec. 22, 2014 ... Pharmaceuticals, Inc. today announced that the Committee for Medicinal ... Agency (EMA) has adopted a positive opinion for the ... of adult men with Peyronie,s disease with a palpable ... at the start of therapy. The use ...
(Date:12/22/2014)... 2014  Eiger BioPharmaceuticals Incorporated announced the positive ... in patients with chronic hepatitis delta virus (HDV) ... Institutes of Health (NIH) Clinical Center in ... placebo-controlled, dose ascending study evaluated two doses of ... twice daily for 28 days.  "This proof-of-concept study ...
Breaking Medicine Technology:Investment Analysis of the US Medical Device Sector 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 3Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 4Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 5Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 6Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 2Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 3
... team of,researchers at West Virginia University has shown ... the habits of their adopted country, increasing,their risks ... cancer,among females., "Breast cancer and prostate cancer ... lifestyle play a major role in these cancers,",said ...
... Limited (ASX:,CYT) today announced that it is commencing ... company,s novel vascular-disrupting anticancer agent,in patients with an ... (GBM)., The GBM clinical trial is the ... tumor indications for the company and the second ...
Cached Medicine Technology:Immigrants From India, Pakistan Face U.S. Prostate, Breast Cancer Risks 2Cytopia Commences Second Phase II Study in Brain Cancer 2Cytopia Commences Second Phase II Study in Brain Cancer 3
(Date:12/24/2014)... Dallas, TX (PRWEB) December 24, 2014 ... has announced the expansion of his practice and med-spa ... to the practice’s growing list of cosmetic treatments and ... a solution into the skin,” says Dr. Ho. “As ... aging changes such as wrinkles, sun spots, discolorations or ...
(Date:12/24/2014)... Today, Yunx.co.uk, a hot style dress supplier that ... occasion outfits, unveils 65 new bridesmaid dresses ... prices, up to 80% off. , Yunx.co.uk’s dresses are ... designs, gorgeous looks and delicate craftsmanship. These new bridesmaid ... to designing and offering high-quality women’s dresses with fast ...
(Date:12/24/2014)... (PRWEB) December 25, 2014 BambooIndustry.com a ... for many years. Today, the company announces its ... a special offer on these new products. , Bamboo ... renewable bamboo. The multiple layer bamboo panel board features ... both strong and emissions free. The bamboo panel consists ...
(Date:12/24/2014)... News) -- Hepatitis C infection does not contribute to mental ... Treatment advances have made it possible for people with ... thinking problems, mood swings and other types of mental impairment ... that long-term infections with other viruses -- a common problem ... of the prime suspects has been the hepatitis C virus, ...
(Date:12/24/2014)... Dec. 24, 2014 (HealthDay News) -- Researchers say they ... that develop into eggs and sperm. While this ... is the first time that these types of cells ... efficiently using human stem cells, according to the team ... creation of primordial germ cells is one of the ...
Breaking Medicine News(10 mins):Health News:Dr. Vu Ho Expands Facial Plastic Surgery Practice to Include New Skin Care Treatment 2Health News:Yunx.co.uk Unveils 65 New Bridesmaid Dresses for the UK market 2Health News:Bamboo Flooring Company Bambooindustry.com Introduces Its Multiple Layer Bamboo Panel Board Collection 2Health News:Hepatitis C Infection Isn't Related to HIV Brain Woes: Study 2
... 20 The following is a statement of ... http://www.newscom.com/cgi-bin/prnh/20080918/CFTFKLOGO ) The ... Harkin (D-IA) for his leadership role in Senate ... Food and Drug Administration (FDA) regulatory authority over ...
... Balance, Inc. (Nasdaq: SMBL ) today held its ... CEO Stephen Hughes spoke to stockholders about the Company,s progress ... year, consumers have found Smart Balance,s brand proposition compelling as ... of spreads," Hughes said. "We are excited as ever ...
... Minnesota MINNEAPOLIS, May 20 Today ClearWay Minnesota,s ... to reducing tobacco,s harm through coalition building, public ... resources to communities outside the Twin Cities metro ... to reducing tobacco,s harm and educate all Minnesotans ...
... the Archdiocese of Boston may soon refer women ... Centene Corp. and archdiocese-run Caritas Christi Health Care.(Logo: ... over the impact of nationalized health care on ... to ethically compromise with a potential federal health ...
... in only one-third of cases, study says , , WEDNESDAY, May ... come to a hospital with the intense chest pain that ... procedures within a few hours, a new Canadian study finds. ... attack and won,t be harmed by waiting a day or ...
... highlighted in June 2009 issue of Pregnancy BALTIMORE, May ... "Website We Can,t Live Without" for June 2009.The website ... rest and preterm labor that is current, concise, and ... and reliable, and then gives women a place to ...
Cached Medicine News:Health News:Sen. Tom Harkin Votes to Protect America's Kids From Tobacco 2Health News:Sen. Tom Harkin Votes to Protect America's Kids From Tobacco 3Health News:ClearWay Minnesota(SM) Board Approves Four Regional Grants 2Health News:ALL: Boston Archdiocese Reportedly on Track for Abortion Referring Venture 2Health News:When Chest Pain Requires Quick Action in ER 2Health News:When Chest Pain Requires Quick Action in ER 3Health News:Pregnancy Magazine Names KeepEmCookin.com its 'Website We Can't Live Without' 2
30 Degree Angle Shaft with 1.0mm 90 Degree Angle Tip; in stainless steel....
0.5mm "K" hook. Rounded knurled handle; shaft angled 11mm from tip; overall length 120mm, in Titanium....
Lightly Curved-Blunt Tips Rounded Blades; 1mm Eye in Blades; 27mm from mid screw to tip. Matte finish; Stainless Steel, overall length 120mm...
... Catheter is indicated for balloon ... of a coronary artery or ... purpose of improving myocardial perfusion. ... also designed to provide distal ...
Medicine Products: