MS Drug Fampridine Sends Acorda Stock Way Up 9 comments
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Acorda Therapeutics (ACOR) announced positive results from its second Phase 3 clinical trial of Fampridine-SR on walking ability in people with multiple sclerosis [MS]. In a timed, 25 foot walk test, just under half of the patients showed improved walking speed vs. placebo. Acorda plans to submit an NDA in 2009.
This was an interesting endpoint. I could be wrong but these two trials from Acorda may have been the only of their kind. Most trials have an endpoint of reduction in MS flare up incidence, or something relapsing remitting related that require a study length of 1-3 years.
MS is characterized by the progressive demylenation of nerves and while most all approved MS therapies are geared towards preventing the immune system from attacking the myelin, Fampridine works on the nerve itself by preventing ions [K+] from leaking out of the damaged neurons and preventing the degradation of the nerve signal.
Acorda got an Special Protocol Assessment [SPA] with the FDA prior to the trials and seems confident of these endpoints, this data support and NDA. While the data doesn ’t knock my socks off (Fampridine only increased average walking speed in 42% of patients and only by 29%) the fact that this may be the first oral therapy approved for MS is a huge deal.
Also in Acorda’s favor is the frighteningly low cost of goods sold. Off hand, I don’t know what the cost will be but Fampridine is simply 4-aminopyridine and must cost fractions of a penny per dose.
Good news all around for both Acorda shareholders and MS patients.
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This article has 9 comments:
The mechanism of action for this compound is unique. Since it doesn't approach MS from an auto-immune vantage point it would make this a natural as an adjunctive therapy.
The unknown is who the Acorda marketing partner would be. The company has a 14-person internal sales force and a 160-member contract sales force selling Zanaflex and this doesn't appear to be the critical mass necessary to provide the educational and marketing effort to have Fampridine-SR recognized as a primary treatment for MS.
At the end of the day, you need to have an innovative molecule coupled with a great company to extol the benefits (and risks) of a particular compound and to make it commercially viable.
Ciao,
Really its awful to see the pain and injection site reactions faced by many MS patients to inject the drugs themselves, so if a oral MS pill is approved then it would be more comfortable for these MS patients!!! So I am waiting to see a satisfied joyous smile on such patients waiting for oral MS drug :-)
Regards,
Shilpa C Nangali
Best regars
Luisa Paes de Vasconcellos
Also, I'd like to mention what Shilpa C Nangali talked about in his comment. Fampridine is not meant to reduce the number of relapses and slow progression like the Interferons, Copaxone, Novantrone and Tysabri are designed to do. It is a drug for help with the severity of the symptoms people with MS experience. It is really wonderful to read what Mr. Nangali said. It's nice to see someone so excited for people with MS. It makes my day. Thanks:)
I just wanted to add my 2 cents here..
Veronica
en.wikipedia.org/wiki/...
On Jan 15 05:56 PM persephone1 wrote:
> I was on the 2nd Phase 3 trial of Fampridine. I have secondary progressive
> MS, and my main symptoms are lack of balance and muscle weakness.
> After a year of taking Fampridine, I can testify to how well it works:
> I can walk much more easily, I'm much more mobile, my muscle strength
> has improved 100%. I could go on--but suffice it to say, without
> Fampridine, I quickly revert to my former state of muscle weakness
> and no balance. This drug is MAJOR. True, it is not a cure, but it
> really helps with many MS symptoms.