Friday, January 29, 2010

FDAs approval of fampridine-SR for multiple sclerosis...

In continuation of my  update on MS, I found this info useful to share with. Multiple sclerosis (MS, also also known as disseminated sclerosis or encephalomyelitis disseminata) is a disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms. Disease onset usually occurs in young adults, and it is more common in females. MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other. Nerve cells communicate by sending electrical signals called action potentials down long fibers called axons, which are wrapped in an insulating substance called myelin.

In MS, the body's own immune system attacks and damages the myelin. When myelin is lost, the axons can no longer effectively conduct signals. The name multiple sclerosis refers to scars (scleroses, better known as plaques or lesions) in the white matter of the brain and spinal cord, which is mainly composed of myelin. (see, picture, source : URMC).

Now FDA has approved fampridine-SR (see structure, source : chemspider),  for the treatment of multiple sclerosis. Most interesting part of the research lies in the fact that Researchers at the University of Rochester Medical Center (URMC) have been evaluating the effects of the drug in MS for more than 10 years- it is the first medication shown to enhance some neurological functions in people with the disease and I think their efforts helped pave the way for action by the FDA.

Researchers at URMC helped develop the study protocols and lead the clinical trials  that demonstrated consistently improved mobility - timed walking speed- in more than a third of patients with MS. This is the first instance in which a drug for multiple sclerosis was found to improve function lost as a result of the disease. Goodman and his colleagues published the results of a Phase 3 clinical trial of the drug in the journal Lancet. Fampridine-SR is being developed by Acorda Therapeutics and marketed under the name Ampyra. The company submitted a new drug application to the FDA in February 2009. An expert advisory panel recommended approval of the drug in October and that recommendation was adopted by the FDA on 23. January 2010.

As per the claim by the researchers, fampridine improves the transmission of signals in the central nervous system of some multiple sclerosis patients by blocking potassium ion channels in nerve cells and restoring signal conduction( have covered an article in the same lines).

The authors claim that, 35% of patients taking the drug were responders who consistently improved their walking speed by an average of about 25%. While walking was the primary measure, patients also reported that they could walk farther distances, climb stairs better, and stay on their feet longer. Except for the mild seizure, at the FDA approved dosage, the drug is safe. Hope, people with MS will have some sort of relief......

Ref :

No comments: