US drugmaker Acorda Therapeutics could be on track to launch a new product into the lucrative market for multiple sclerosis treatments, if positive results in a Phase III trial are backed up in further studies.
Acorda said yesterday its Fampridine-SR (4-aminopyridine) compound was able to help MS patients walk more quickly and improved their leg strength. The drug blocks specialised potassium channels in neurons and is thought to stop nerves that have lost their myelin sheaths – a hallmark of MS - from short-circuiting.
In the trial, a significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (35% vs. 8%; p < 0.001). The effect was maintained throughout the 14-week treatment period.
The positive results in MS breathe new life into a project that suffered a major setback in 2004, when two Phase III trials in spinal cord injury patients failed to demonstrate a significant benefit for Fampridine-SR compared to placebo.
On the back of the new data, Acorda plans to meet with the FDA and discuss how to progress the development programme for Fampridine-SR in MS. The company’s share price all-but tripled on the announcement, reaching $8.508 by market’s close yesterday.
The company already markets Zanaflex (tizanidine HCl) for spasticity, which brought in around $8 million in sales in the second quarter of 2006, but if approved for MS Fampridine-SR could present a sizeable market opportunity, as it could be used alongside current treatments for the disease such as beta interferons and Teva’s Copaxone (glatiramer acetate).