On October 29, 2010, Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis (MS). PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.
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FDA Approves First Oral Treatment for Relapsing Forms of MS
Novartis Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). Gilenya is the first oral disease-modifying therapy available for the long-term treatment of MS. The approval of a treatment that may be taken orally (by mouth), versus injection or infusion, is exciting news for members of the MS community.
Read News ArticleFDA Committee Recommends the Approval of FTY720
The oral medication FTY720 (fingolimod) has moved another step closer to approval as a new disease-modifying therapy for MS. The United States Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee reviewed the clinical trial data submitted by Novartis Pharmaceuticals Corporation (makers of FTY720), and reported its findings at a meeting held on June 10, 2010.
Read News ArticlePhase 2 CHOICE Study Reports Positive Effects with Daclizumab
Biogen Idec and Facet Biotech Corporation, developers of daclizumab, report that when added to an interferon regimen, this drug reduces the number of new or enlarged MS lesions in patients with active, relapsing forms of MS. Additionally, daclizumab showed an increase in the number of a certain type of cell that helps to regulate the immune system. These results were published in the online edition of The Lancet Neurology and in the April 2010 issue of The Lancet Neurology.
Read News ArticleContinued Efficacy and Safety Seen with 15-Year Evaluation of Copaxone
In February 2010, Teva Pharmaceutical Industries Ltd. announced the publication of their data from 15 years of prospective and continuous evaluation of Copaxone®. The 15-year study findings appeared in the February 2010 issue of the journal, Multiple Sclerosis. Given the positive results, this study has been extended to 20 years, and is presently in its 19th year. Copaxone is given via daily subcutaneous injections and is approved for individuals with relapsing-remitting MS (RRMS).
Read News ArticlePositive Study Results with Oral FTY720 Leads to Granting of Priority Review Status by FDA
In January 2010, the results from two large Phase III trials with oral FTY720 (fingolimod) were published in The New England Journal of Medicine. According to a press release from Novartis Pharmaceuticals Corporation (makers of FTY720), the TRANSFORMS and FREEDOMS studies showed positive results in reducing relapses, disability progression, and MRI lesions when MS patients were given FTY720.
Read News ArticleFDA Approves Botox for Upper Extremity Spasticity
The United States Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxin A) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Manufactured by Allergan, Inc., this drug is administered via injection by a medical professional and is available through prescription only.
Read News ArticleMarch is Multiple Sclerosis Awareness Month
The Multiple Sclerosis Association of America (MSAA) encourages everyone to take time this March to learn about multiple sclerosis (MS) and discover all of the programs and services MSAA offers to everyone affected by MS.
Read News ArticleIn Memory of Jimmie Heuga (1943-2010)
Jimmie Heuga, founder of The Heuga Center for Multiple Sclerosis in Colorado, passed away on February 8, 2010. Renamed "Can Do Multiple Sclerosis," this center continues to carry on Heuga’s philosophy and passion for teaching individuals with MS to live life to the fullest.
Read News ArticleAmpyra Approved to Improve Walking for Individuals with MS
The United States’ Food and Drug Administration (FDA) has approved Ampyra™ (dalfampridine), an oral, timed-release medication developed to improve the conduction of impulses between damaged nerves of the central nervous system (CNS).
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