The first studies of this potassium-blocking approach in people with MS were supported by the National MS Society.
This is the first therapy specifically approved to treat a symptom of MS, and it represents a big step forward for the many people who might benefit. Several resources are available for those interested in learning more.
A National MS Society video webcast/podcast from MS Learn Online that discusses Ampyra is now available.
Acorda has established a phone line that individuals may call for information: 1-888-881-1918.
The full label with prescribing and patient information guide is now available on the FDA’s Website (.pdf)
As with all medications, Ampyra (pronounced am-peer-ah) will not be 100 percent effective for 100 percent of people with MS; however, it has been demonstrated in clinical trials to improve walking speed by 25 percent. This improvement in walking speed is a result of better conduction of impulses from the brain to the muscles because the drug can block potassium from entering nerves. When the MS disease process strips myelin away, potassium can enter nerves and damage them.
While this medication is appropriate for patients with all forms of MS, be they relapsing or progressive, the decision to use the drug is one that should be considered carefully between you and your doctor. The FDA did note that the drug should NOT be taken by individuals with a history of seizures, or by those with moderate to severe renal impairment.
It’s important to be mindful that Ampyra, which is a tablet taken twice-daily by mouth, is a symptomatic treatment, and not a disease-modifying therapy. While this treatment may improve walking speed, it has no effect on the underlying disease process. Even so, it’s a very good thing to have symptomatice medication to help with treatments, especially in patients who might not respond fully to the disease-modifying drugs.
Walking disability is one of the most common symptoms of MS. The management of mobility problems is imperfect. Baclofen is of benefit to treat spasticity or stiffness, and physical therapy and exercise are helpful as well. Ampyra impacts motor fatigue as well as walking speed, and is particularly effective in those whose walking is effected adversely by heat, that is those with heat intolerance.
Further study and clinical practice may help determine the extent to which the drug may impact other functions not measured in the clinical trials, and provide hints as to which individuals are most likely to respond.
As with any drug, there are side-effects to consider. Those experienced most often by patients in the Phase III trial included back pain, dizziness, insomnia, fatigue, nausea, balance disorder, urinary tract infection, falls, and headache. Two serious adverse events led participants to discontinue taking the drug (one case of anxiety and one seizure in a person who developed sepsis from a urinary tract infection).
According to a company press release on February 3, 2010, the wholesale price of Ampyra will be $1,056 per 30-day supply. The actual retail cost to an individual will depend on many factors, such as the cost negotiated by his or her insurer. Talk to your physician and see if you are a candidate for Ampyra.
By Martha King
In addition to labels like relapsing-remitting MS, secondary-progressive MS, primary-progressive MS, there is something labeled benign MS for people who live with MS for years without developing any disabilities at all.
Like so much else in MS, no one understands why some MS is so mild. Even the proportion of people with benign MS is unclear. Estimates range from 5% to 40% in different studies, and some doctors have even called for a halt in the use of this term.
Everyone agrees that benign describes the very mildest form of MS. These people have had enough neurological symptoms and MRI abnormalities to be diagnosed — but for the next 10 to 20 years, their physical disability is mild to nonexistent.
The big catch
Early on—which is the very best time to get on a disease-modifying drug—there is no way to predict who will have mild MS and who needs to start therapy as soon as possible. Teasing out the factors that distinguish the “benign” group from others would spare them from taking treatment they don’t need. The factors might also be clues to preventing more disabling MS. Researchers are eager to dig in.
Investigators in Europe are pooling their imaging expertise in an ongoing collaborative MS research project called MAGNIMS. A recent report from this project warns against assuming mild MS is truly benign.* MAGNIMS researchers found cognitive impairment in up to 45% of people who had been designated as “benign.” They concluded that testing to rule out cognitive problems is essential before a person is considered to have truly benign MS.
The MAGNIMS team also saw some MRI abnormalities that suggested a future of worsening MS and they identified a connection between mild MS and a brain’s ability to compensate for damage by mobilizing other brain regions. In other words, some mild MS had caused real but hidden damage.
The best idea for now
The MAGNIMS analysis adds important insights into “benign MS” — and makes a clear case for further research involving large numbers of people with mild MS. Until more is known, the Society’s National Clinical Advisory Board recommends that treatment with one of the disease-modifying MS drugs be considered as soon as possible following a confirmed MS or CIS diagnosis. To learn more, visit the National MS Society Web site, nationalMSsociety.org and look for Benign MS in our Research/Clinical Updates.
CCSVI or Blood Flow in the Brain and Venous Insufficiency in MS
Recent preliminary studies indicate that a phenomenon called CCSVI, a reported abnormality in blood drainage from the brain and spinal cord, may contribute to nervous system damage in MS. This hypothesis has been put forth by Dr. Paulo Zamboni from the University of Ferrara in Italy. Based on the results of his initial preliminary findings, Dr. Zamboni states that this pilot study warrants a subsequent larger and better controlled study to definitively evaluate the possible impact of CCSVI on the disease process in MS.
It has been proposed by Dr. Zamboni for further study that CCSVI may be corrected through endovascular surgery, which involves inserting a tiny balloon or stent into blocked veins in order to permit the flow of blood out of the brain and spinal cord, a procedure that has been called “liberation therapy” in some reports.
The National MS Society is pursuing this potential MS lead by undertaking the funding of new research on CCSVI in MS and has invited investigators worldwide to apply for grants on this topic.
Australian Study Questions Established Concepts of Early Disease Events In MS
Investigators at the University of Sydney have published a study suggesting that the earliest activity seen in the brain in MS is the destruction of cells that make myelin (oligodendrocytes), occurring before the onset of immune activity usually blamed for triggering the disease. This provocative study, co-funded by many sources including the National MS Society, opens up new possibilities for finding the cause of the disease and developing new treatments. In tissues surrounding newly forming lesions, the investigators found evidence of the loss of oligodendrocytes with an absence of immune T or B cells that would normally be held responsible for launching the immune attack against oligodendrocytes and the myelin they produce. These and other immune cells, including scavenger cells (macrophages and microglia), were more numerous in lesions and surrounding tissues at apparently later stages of destruction and sometimes in lesions that were in the process of repair. These and other unexpected findings from this study led the investigators to propose that the early immune activity seen in active lesions is that of macrophages and microglia, whose job it is to clean up and remove damaged myelin. This study is a significant addition to a small but growing body of evidence that highlights the question of what triggers MS and whether there is something other than, or in addition to, the immune attacks that lead to tissue damage in the brain and spinal cord of people with MS.
Positive Results Published on Clinical Trials of Oral FTY720 (Fingolimod) for Relapsing MS -- FDA Grants Priority Review Status. There are currently no approved oral disease-modifying therapies for MS. Positive results from two large-scale phase III clinical trials of Gilenia –the oral drug for Relapsing MS formerly known oral fingolimod (FTY720) - have been published showing it significantly reduced multiple sclerosis relapse rates. One of the trials also suggested it could slow the progression of disability. Novartis applied to the FDA for approval of Gilenia in December and has been granted a priority review .
“Priority review” designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. It means that the time it takes FDA to review a new drug application is reduced. The goal for completing a priority review is six months from the application date, but this period could be extended if the FDA requires additional time to evaluate any risk management program that might be proposed for Gilenia.
Migraine More Common in Women with MS
Migraine is seen more frequently in women with multiple sclerosis (MS) than those without, according to a study released in February that will be presented at the American Academy of Neurology’s 62nd Annual Meeting in Toronto in April.
“While having a history of migraine diagnosis was linked to MS, women with migraine need to know that over 99 percent of them will never develop MS, thus having migraine should definitely not be a reason to worry about getting MS,” said study author Ilya Kister, MD, with New York University School of Medicine and a member of the American Academy of Neurology. “More research is needed since it’s still not known whether migraine is a risk factor for developing MS or if it is a condition that occurs at the same time as MS.”
The study involved 116,678 women who were part of the Nurses’ Health Study II. Of these women, 18,000 had been diagnosed with migraine at the start of the study. The women were followed every two years for 16 years. During the study, 375 women were diagnosed with MS. Of those, 82 had reported at the beginning of the study that they had been diagnosed by a doctor with migraine.
The study found that women with a migraine diagnosis at the beginning of the study were 47 percent more likely to develop MS than women without a diagnosis. The results were the same regardless of age, where they lived, Scandinavian ancestry, vitamin D levels, smoking status and body mass index.
The research represents the first large scale study of its kind to explore the relationship between migraine and MS.
More data on this relationship will be at the American Academy of Neurology Annual Meeting in Toronto.
- CenterWatch www.centerwatch.com
- NARCOMS www.mscare.org/cmsc/CMSC-NARCOMS-Information
- MS-CORE www.ms-core.org
- MS International Federation www.msif.org/en/research/clinical_trials
- TCISCRP www.ciscrp.org
- ResearchMatch.org www.researchmatch.org