Ampyra (Fampyra)

Ampyra (Fampyra)


Seeing the drug referred with two names confused me because separate press releases never mentioned the drug is called by either name... but the M.S. Resource Center of the U.K. makes it clear.


 http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1310/text/3

Ampyra (Fampyra)

 

Ampyra (Fampridine-SR) is a sustained-release tablet formulation of the drug fampridine (4-aminopyridine, or 4-AP). 

Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.

Biogen Idec Canada announces that Fampyra (fampridine sustained release tablets or fampridine SR) is now available for prescription for patients living with multiple sclerosis (MS) in Canada.  Health Canada approved Fampyra on February 10, 2012 for the symptomatic improvement of walking in adult MS patients with walking disability (EDSS 3.5-7). Walking impairment is one of the most common and disruptive consequences of MS and Fampyra is the first approved treatment that addresses this unmet medical need. In clinical trials, it demonstrated efficacy in people with all types of MS. Patients with MS consistently rate walking as the most important function they want to maintain, regardless of what stage they are in their disease. Walking impairment is directly associated with loss of independence, restrictions on a patient's ability to work and a reduction in overall levels of household income. In fact, a research survey shows that 88 per cent of sampled Canadians living with MS report that difficulty walking affects their overall mobility. "For patients with MS, one of the greatest areas affected in their lives is walking. Until fampridine SR (Fampyra), there have been no pharmacologic agents shown to directly improve walking function in persons with multiple sclerosis," said Dr. Christine Short, Associate Professor, Department of Medicine, Division of Physical Medicine and Rehabilitation, Dalhousie University, Halifax, NS. "As a clinician who manages persons with multiple sclerosis, the approval of this treatment in Canada represents a real breakthrough in our battle to help individuals maintain independence and quality of life in the face of a progressive neurologic disease." MS is an unpredictable, often debilitating disease of the central nervous system that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage. When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted. Studies show that Fampyra can increase conduction along damaged nerves and enable signals to pass down the nerve more normally, which may result in improved walking for adult MS patients. Clinical Data Demonstrates Efficacy The approval of Fampyra for the improvement of walking in adult patients with MS was based on the results of two Phase III clinical trials: MS-F203 and MS-F204. The primary endpoint was the responder rate based on walking speed as measured by the Timed 25-Foot Walk (T25FW). A significantly greater proportion of patients taking Fampyra had consistent improvement in walking speed when compared to placebo (ms-f203:34.8 per cent to 8.3 per cent)(and ms-f204:42.9 per cent to 9.3 per cent). In patients who responded to therapy in the two studies, MS-F203 and MS-F204, Fampyra increased their walking speed on average by 26.3 per cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent, respectively. "Seeing the effects of these results will have an important impact on patients," said Dr. Brad Stewart, Neurologist and Assistant Clinical Professor, University of Alberta, Edmonton, Alberta. "As mobility impairment in MS is progressive, Fampyra is a welcomed, new treatment to address this unmet need in the management of walking difficulties." Important Safety Information The use of Fampyra is contraindicated in patients with a known hypersensitivity to fampridine or any ingredient in the formulation; currently on treatment with other forms of 4-aminopyridine, dalfampridine or fampridine; with a history of mild, moderate or severe renal impairment; or with a history of seizure or medically assessed as at high risk of seizure. Fampyra should only be used under the supervision of a clinician experienced in the treatment of MS and familiar with the safety and efficacy of Fampyra. The recommended dose of one sustained release 10 mg tablet twice daily, taken 12 hours apart, should not be exceeded. The most common adverse events with incidence greater than or equal to two per cent and at a rate greater than the placebo rate for Fampyra were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, paraesthesia, nasopharyngitis and constipation. Source: Market Watch Copyright © 2012 MarketWatch, Inc (11/04/12) Interactive website for Ampyra® (Dalfampridine) MS users launched   Acorda Therapeutics, Inc. has announced the launch of a new interactive patient website called Ampyra Journeys. The site is the first-ever stand-alone patient site to focus on walking problems associated with multiple sclerosis (MS). Ampyra (dalfampridine) is an oral medication approved by the FDA as a treatment to improve walking in patients with multiple sclerosis. This was demonstrated by an increase in walking speed. The Ampyra Journeys website features true stories of people living with MS who have experienced walking problems and who took action to get treatment. Their stories explore the impact that walking problems can have for people living with MS, and how treatment that leads to improvements in walking can help people to regain the ability to perform many daily tasks. Prominent MS patient advocate, motivational speaker and entertainer Kristie Salerno Kent is among the patients who share their personal stories on www.AmpyraJourneys.com. “I have met so many people living with MS who did not seek help when they started to experience walking problems. The important news is that treatment is available, and so I am very excited to be involved with Ampyra Journeys. This new website is a vital resource that can help anyone living with MS to learn about, and to do something about, MS-related walking problems,” said Ms. Salerno Kent. Walking problems are a significant concern for people living with MS. According to a 2011 Harris Interactive Survey, approximately 70% of people with MS who experience difficulty walking identify this issue as the biggest challenge associated with MS. Visitors to the website can also download “Let’s Talk About Walking and MS,” a guide with tips on how to talk about walking problems with a healthcare provider. “Acorda Therapeutics developed Ampyra to help patients with walking problems, one of the most challenging and common symptoms of MS. Now we are very pleased to present Ampyra Journeys, to help more people get the support they need to get treatment. It's our hope that this site will educate and inspire people to seek help for their MS-related walking problems,” said Ron Cohen, MD, president and CEO of Acorda Therapeutics. Source: EON ©2012 Business Wire (03/04/12) Ampyra® shows improvement of patient-reported walking ability \ \ Acorda Therapeutics, Inc. announced an analysis of pooled clinical trial results showed patients who were responders to Ampyra® (dalfampridine) Extended Release Tablets, 10 mg demonstrated clinically relevant improvements in walking ability as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), regardless of either their baseline Expanded Disability Status Scale (EDSS) score or baseline walking speed. The data were presented at the 2011 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held June 1-4 in Montreal, Canada. Ampyra is an oral medication approved by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. "People with MS often experience a progressive decline in their walking ability that can begin early in their disease course. However, in many cases patients and their healthcare providers do not discuss walking impairment until it is so severe that it requires physical support from canes or walkers,” said Ron Cohen, M.D., Acorda's President and CEO. “These data show that people with MS, even those with less obvious walking impairment, can potentially experience meaningful clinical benefit from treatment with Ampyra.” The poster presentation, entitled “Impact of Dalfampridine on MSWS-12 Score Change in MS Patients” (poster S70), examined improvements in walking ability as measured by the MSWS-12 when patients were stratified using two separate criteria: EDSS score and baseline walking speed as measured by the Timed 25-Foot Walk (T25FW). The MSWS-12 is a patient-reported questionnaire that assesses the impact of MS on various aspects of walking ability in everyday life. The presentation was based on a pooled analysis of data from one Phase 2 and two Phase 3 clinical trials of dalfampridine, which were the pivotal trials included in the New Drug Application that formed the basis of the U.S. Food and Drug Administration approval of the drug. When stratified by baseline EDSS score (≤4.5, 5.0-5.5, ≥6.0), improvements in MSWS-12 scores among Ampyra responders were clinically relevant and substantially greater compared to non-responders and placebo-treated patients across all three EDSS groups. Responders were defined as patients whose walking speed was faster on at least 3 of 4 on-treatment visits than their fastest speed at any of 5 off-treatment visits. Similarly, when patients were stratified into four groups by baseline walking speed, Ampyra responders experienced clinically relevant improvements across all four groups. A second poster on Ampyra data presented at the CMSC meeting, “UTI Incidence Among MS Patients Treated with Dalfampridine 10 mg Twice Daily” (poster S157), analyzed the incidence of urinary tract infection (UTI) reported by MS patients treated with Ampyra in clinical trials, extension studies, and postmarketing safety reports. Approximately 80% of newly diagnosed MS patients and up to 96% of patients who have had MS for 10 years or more normally experience some bladder dysfunction, and UTI is a frequent complication of this dysfunction1. In the pooled Phase 2 and Phase 3 clinical trial data of 400 patients receiving Ampyra twice daily and 238 patients receiving placebo referenced above, 14.5% of Ampyra-treated patients reported experiencing a UTI compared to 9.2% of placebo-treated patients over treatment observations periods of 9 to 14 weeks. The incidence of serious UTIs was similar across the Ampyra and placebo groups; there were no discontinuations in the clinical trials due to UTI as an adverse event. Neither urinalysis nor culture was required for a UTI diagnosis in the clinical trials, which was usually based on symptoms. Among 483 patients who enrolled in Ampyra open-label extension studies, UTI was reported in 33.1% of patients, with observation periods ranging from 1-182 weeks. Postmarketing safety reports showed that 0.5% of Ampyra-treated patients reported symptoms suggestive of a UTI (238/46,000 patients; data through April 2011); less than 10% of these reported UTIs were confirmed by urinalysis or culture, suggesting that most diagnoses were based on symptoms rather than recommended diagnostic criterion. Ampyra is marketed in the United States by Acorda Therapeutics, Inc. It is approved in the Unites States as a treatment to improve walking in people with MS. This was demonstrated by an increase in walking speed. Source: Acorda Therapeutics (06/06/11)