Followers | 435 |
Posts | 57599 |
Boards Moderated | 5 |
Alias Born | 01/09/2007 |
Friday, January 22, 2010 4:35:46 PM
just before market closed .. courtesy
of cnbc's mike huckman
excellent timing .. :)
--
FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
By: PR Newswire | 22 Jan 2010 | 03:37 PM ET Text Size
SILVER SPRING, Md., Jan 22, 2010 /PRNewswire via COMTEX/ -- The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) MS is a chronic, often disabling, disease that affects the central nervous system--the brain, spinal cord, and optic nerves. There are about 400,000 people in the United States and 2.5 million people world-wide with MS.
The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. About half of all people with MS experience cognitive impairments like difficulties in concentration, attention, memory, and judgment, although these symptoms are usually mild and are frequently overlooked. Depression also is common among MS patients.
"Trouble with walking is one of the most debilitating problems people with MS face," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Ampyra, when given at doses greater than that recommended (10 milligrams twice a day), can cause seizures. The most common adverse reactions reported by patients taking Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin.
Ampyra should not be used in patients with moderate to severe kidney disease. In these patients, blood levels with the drug approach those associated with the occurrence of seizures.
Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by Acorda Therapeutics Inc. of Hawthorne, N.Y.
For information about FDA drug approvals: http://www.fda.gov/Drugs/default.htm.
Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov SOURCE U.S. Food and Drug Administration www.prnewswire.com Copyright (C) 2010 PR Newswire. All rights reserved -0- KEYWORD: Maryland INDUSTRY KEYWORD: HEA
MTC
PHA SUBJECT CODE: POL
FDA
EXE
TRI
---
4kids
all jmo
10/5/07 -- there are no coincidences here ...
oh and like many other longs .. not selling at this level --
FEATURED DaBaby and Stunna 4 Vegas's "NO DRIBBLE" Joins Music Licensing, Inc.'s Portfolio • Jun 7, 2024 10:15 AM
Mushrooms Inc. (OTC: MSRM) Announces Significant Share Buy Back by the Board Director and New Strategic Initiatives. • MSRM • Jun 5, 2024 1:32 PM
Hydromer Announces Launch of HydroThrombX Medical Device Coating Technology • HYDI • Jun 5, 2024 10:24 AM
Dr. Michael Dent Finances $1 Million to Drive HealthLynked's Healthcare Transformation • HLYK • Jun 5, 2024 8:00 AM
Avant Technologies Enters Binding LOI to Purchase Dozens of High-Performance, Immersible, AI-Powered Servers • AVAI • Jun 5, 2024 8:00 AM
IQST - iQSTEL Announces $290 Million 2024 Annual Revenue Forecast • IQST • Jun 4, 2024 1:43 PM