New Drug for Multiple Sclerosis Tied to Our Medical Facility

New Drug for Multiple Sclerosis Tied to Our Medical Facility

In a significant breakthrough for those living with Multiple Sclerosis (MS), the Food and Drug Administration (FDA) has approved the drug fampridine-SR for the treatment of the debilitating disease. The drug, marketed as Ampyra by Acorda Therapeutics, has been shown to enhance some neurological functions in people with MS.

Fampridine-SR primarily improves neurological function in MS by enhancing nerve signal conduction, leading to better walking ability and moderate improvements in daily function for some patients. This is achieved by blocking potassium channels on nerve fibers, helping restore conduction in demyelinated motor neurons affected by MS.

The drug has been found to increase walking speed, as measured by tests like the Timed 25-Foot Walk (T25FW). This improvement is considered clinically meaningful, though modest, and occurs in a subset of patients with moderate disability (Expanded Disability Status Scale [EDSS] scores of 4-7).

Patients taking the drug have also reported improved self-reported walking ability and functional status, demonstrated by better scores on the 12-item MS Walking Scale (MSWS-12). Additionally, the drug may help other neurological functions such as finger dexterity and possibly some brain function, though walking improvements are the most well-documented and primary benefit.

The improvements translate to better mobility and enhanced quality of life in daily activities for responders, although not all patients experience benefit. This is because walking impairment in MS arises from a complex interplay of factors beyond nerve conduction alone, including coordination, balance, vision problems, and neuronal loss rather than just demyelination.

Common side effects from fampridine-SR are generally mild to moderate. The efficacy and safety of the drug have been confirmed in controlled clinical trials involving several hundred patients over weeks of treatment.

The FDA's approval of fampridine-SR follows an expert advisory panel's recommendation in October 2020. Researchers at the University of Rochester Medical Center, who have been evaluating the effects of the drug in MS for over 10 years, helped develop the study protocols and lead the clinical trials that demonstrated improved mobility in more than a third of patients with multiple sclerosis.

Dr. Andrew Goodman, chief of the University of Rochester Medical Center's Multiple Sclerosis Center, stated that the drug will provide a new tool for physicians and may help improve walking and regain some independence for patients.

Multiple sclerosis is a disease of the central nervous system and is the most common cause of neurological disability in young adults. An estimated 2.5 million people worldwide suffer from the condition, characterised by symptoms such as gait difficulties, muscle weakness, numbness or tingling in arms and legs, difficulty with coordination and balance, blurred vision, and slurred speech.

The primary obstacle in developing treatments for MS has been that most drugs are measured by their ability to prevent relapses or slow the progression of the disease, not reverse symptoms once they became established. However, fampridine-SR represents a new approach, as it is the first drug for MS to improve function lost as a result of the disease.

While the most concerning risk identified in clinical trials is the potential for seizures, the incidence of seizure-related events has remained relatively low at the dose approved by the FDA.

In the Lancet study, 35% of patients taking the drug were responders who consistently improved their walking speed by an average of about 25%. Patients also reported that they could walk farther distances, climb stairs better, and stay on their feet longer.

The license to develop fampridine was acquired by Acorda Therapeutics, and the drug is now available for prescription in the United States. The approval of fampridine-SR marks a significant step forward in the treatment of MS, offering hope for improved mobility and quality of life for those affected by the disease.

1. The new drug, fampridine-SR, approved by the FDA for the treatment of Multiple Sclerosis (MS), has been shown to improve walking ability and daily function in some patients, primarily by enhancing nerve signal conduction.
2. The improvements in mobility observed in clinical trials for fampridine-SR, such as increases in walking speed, are clinically meaningful, though modest, and occur in a subset of patients with moderate disability.
3. The FDA's approval of fampridine-SR signifies a significant advancement in science and health-and-wellness, as it is the first drug for MS to improve function lost due to the disease, offering therapies-and-treatments for improving the quality of life for those living with neurological-disorders like MS.

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