Rochester, NY, January 23 -- The Food and Drug Administration (FDA) gave its nod to a drug meant for patients suffering from multiple sclerosis (MS) and those who experience difficulties in walking.
Ampyra (generic name dalfampridine, formerly known as fampridine), the drug from the repertoire of Acorda Therapeutics Inc (ACOR.O), is the first ever MS therapy that is taken orally.
Walking deformities most debilitating
The National Multiple Sclerosis Society defines MS as a "chronic, a disabling disease that attacks the central nervous system having symptoms as extreme fatigue, difficulty walking, problems with memory and heat sensitivity.”
As on date, there is no cure for multiple sclerosis, a chronic disease affecting close to 2.5 million people globally.
The most common form of MS is relapsing-remitting, wherein patients have acute attacks followed by periods of remission. However, data also suggests that three-fourth of the MS patients have difficulty in walking.
Of the total patients who experience walking deformities, 70 percent term it as the most challenging aspect of their disease. Walking ability tends to worsen with time and invariably patients require wheelchairs.
"Trouble with walking is one of the most debilitating problems people with MS face," noted Dr. Russell Katz, head of the FDA division that reviewed Ampyra.
The FDA approval may spell a reduction in the woes of patients suffering from this incriminating disease.
Not a panacea
The clinical trials of the drug, some of which were led by Dr. Andrew D. Goodman, MD, director of the MS centre at the University of Rochester, New York, revealed that participants who were administered Amprya had faster walking speeds vis-à-vis participants who took a placebo.
The clinical trials were conducted on 500 participants under two different studies. The speed with which these participants could walk a distance of 25 feet (8 meters) was measured and a comparison was made between participants who took either Ampyra or a placebo.
Ampyra is prescribed with other MS drugs and prevents the condition from deteriorating.
Amprya is not the cure for MS; however, the drug does improve the nerve system functioning of the patients.
The FDA panel has given a green signal to the drug, stating that the company’s data showed Amprya to be safe and effective.
Amprya is likely to hit the shelves by March this year, claims Acorda Chief Executive Ron Cohen.
Although no sales projections were given by the CEO, Merriman Curhan Ford & Co analyst, Mike King, estimates that, globally, Ampyra will register sales of $1 billion by 2015 or 2016.