Multiple Sclerosis Dalfampridine Extended Release Tablets—Clinical Need and Use Aaron Miller, MD, FAAN,1 Amy Perrin Ross, APN, MSN, CNRN, MSCN2 and James Gilbart, PhD3
1. Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis and Professor of Neurology, Mount Sinai School of Medicine; 2. Neuroscience Program Co-ordinator, Department of Neurosciences, Loyola University Chicago; 3. Senior Medical Writer, Touch Briefings
Abstract
Walking impairment is one of the most serious and frequent problems reported by multiple sclerosis (MS) patients. Treatments to restore walking ability are an unmet clinical need. Dalfampridine, a potassium channel blocker, is the first US Food and Drug Administration (FDA)-approved drug to be indicated specifically to improve walking in patients with MS. In clinical trials the drug showed improved walking speeds, demonstrating efficacy in all four types of MS. In phase III trials, dalfampridine provided significant benefits to 35–43% of treated patients. Therefore, it will be critical to manage patient expectations appropriately.
Keywords 4-Aminopyridine, dalfampridine, fampridine, multiple sclerosis, walking impairment
Disclosure: Aaron Miller, MD, FAAN, has received research support from Acorda, Teva, Novartis, Genentech, Genzyme, sanofi-aventis, and Biogen Idec, has acted as a consultant to sanofi-aventis, Biogen Idec, Glaxo Smith Kline, EMD Serono, Daiichi Sankyo, Merck Serono, Novartis, ONO, Acorda, BioMarin, Avanir, Chelsea Therapeutics, Nuron Biotech, and La-Ser, and is on the speakers bureau for Biogen Idec, Pfizer, EMD Serono, Teva, and Acorda. Amy Perrin Ross, APN, MSN, CNRN, MSCN, has acted as a consultant to, is on the speakers bureau for, or has received honoraria from Bayer Healthcare, Pfizer Inc., EMD Serono, Teva, Acorda, Genzyme, Novartis, Biogen Idec, and Questcor. James Gilbart, PhD, is a Touch Briefings employee. Received: November 12, 2010 Accepted: December 20, 2010 Citation: US Neurology, 2011;6(2):76–81 Correspondence: Aaron Miller, MD, FAAN, Mount Sinai School of Medicine, 5 East 98th Street, 1st Floor, New York, NY 10029. E:
aaron.miller@
mssm.edu
Support: The publication of this article was funded by Acorda Therapeutics Inc. The views and opinions expressed are those of the authors and not necessarily those of Acorda Therapeutics Inc.
Multiple sclerosis (MS) affects more than 2.1 million people worldwide and is the most common cause of non-traumatic chronic neurological disability in young and middle-aged adults.1,2
MS is associated with a considerable economic burden from medical costs and lost productivity.
MS presents patients with many challenges, among which walking impairment is one of the most serious. Walking impairment is most prevalent in patients who have had progressive MS for many years, but subtle changes in walking and gait may be discerned even in patients with recent disease onset.3
These may not be apparent to observers,
including healthcare providers, and may not be detectable in a routine physical examination. Decreased walking ability is regarded by most MS patients as the worst consequence of MS and has the most serious impact on their ability to continue in employment and to participate in leisure and social activities.4,5
Therefore medications that can help restore walking ability in MS are greatly needed.6
While drugs such as baclofen and tizanidine are routinely prescribed to reduce spasticity in MS patients,2
used in recent pivotal clinical trials in MS. Dalfampridine gained US Food and Drug Adminstration (FDA) approval for the improvement of walking in patients with MS, as demonstrated by an increase in walking speed in January, 2010, and was the first drug approved for this indication.2,7 Dalfampridine is also known by its previous US Adopted Name (USAN) and current International Nonproprietary Name (INN), ‘fampridine’, as well as its chemical name ‘4-aminopyridine’ (4-AP).
The purpose of this article is to discuss the clinical need for a treatment to improve walking ability in MS. The discussion will consider the extent to which dalfampridine fulfills this need and how the expectations of patients receiving dalfampridine can be managed.
The Need for Treatments of Walking Impairment in Multiple Sclerosis
dalfampridine is the first drug
specifically intended to improve walking in MS by targeting the neuropathology of demyelination. Dalfampridine extended release tablets (referred to in this article as ‘dalfampridine’) was the formulation
76
In MS, walking impairment is a frequent and serious problem. A majority (64–85%) of MS patients report some degree of walking impairment and 70% of people with walking difficulty as a result of MS report it to be the most challenging aspect of the disease.8,9
The effect of MS on walking
ability is often evaluated using the Expanded Disability Status Scale (EDSS) and the MS functional composite, which include walking performance as a major component.
© TOUCH BRIEFINGS 2010
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