Ampyra
Publisher: Datamonitor Healthcare
- Description
- Contents
- Enquire
Analyst Outlook
Ampyra (dalfampridine; Acorda Therapeutics/Biogen) is the only approved drug specifically to improve
walking in patients with multiple sclerosis. Despite not being a disease-modifying drug, Ampyra can
still be used in a large proportion of multiple sclerosis patients due to the high prevalence of
ambulatory symptoms among sufferers. Its moderate efficacy and seizure risk leave room for potential
competitors to improve upon Ampyra, but it has nevertheless performed well commercially since its
first launch in 2010.
Drug Overview
Ampyra is a potassium channel blocker, marketed by Acorda Therapeutics and Biogen, which is
approved to improve walking ability in multiple sclerosis patients. Although Ampyra’s active molecule
fampridine (4-aminopyridine) is readily available, by using Elan’s Intestinal Protective Drug Absorption
System, Acorda has developed a sustained-released oral tablet formulation allowing twice-daily
dosing. Acorda hopes this is a significant improvement on fampridine because there is a narrower
toxic to therapeutic range and the most debilitating side effects occur at high plasma concentrations.
In January 2010, following advisory panel concerns that the drug showed an increased risk of seizures,
the US Food and Drug Administration (FDA) approved Ampyra with a Risk Evaluation and Mitigation
Strategy (REMS) program comprising of a medication guide and communication plan (BioMedTracker,
Copyright 2015, reprinted with permission). This made Ampyra the first drug to gain FDA approval as a
treatment to improve walking in patients with multiple sclerosis, for which it has orphan drug status.
The drug was later approved in the EU in July 2011 with the brand name Fampyra, where it is
marketed by Biogen.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Ampyra : Multiple sclerosis
11 Ampyra : Stroke
LIST OF FIGURES
6 Figure 1: Ampyra for multiple sclerosis – SWOT analysis
14 Figure 2: Ampyra for ischemic stroke – SWOT analysis
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ampyra in ischemic stroke
15 Figure 4: Datamonitor Healthcare’s drug assessment summary of Ampyra in ischemic stroke
LIST OF TABLES
4 Table 1: Ampyra drug profile
5 Table 2: Ampyra pivotal trial data in multiple sclerosis
11 Table 3: Ampyra drug profile
13 Table 4: Ampyra Phase III trials in ischemic stroke
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Key Trends in European Market Access 
Sign up to the