FDA Approves Ampyra fampridine-SR

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FDA Approves Ampyra fampridine-SR

Postby Bibek » Sat Jan 23, 2010 5:16 am

Hi All,
Good News !!!!




FDA approves Ampyra ,the first MS drug of its kind to improve walking speed

FDA approves drug for multiple sclerosis
By Georgiann Caruso, CNN Medical News
January 22, 2010 8:03 p.m. EST
EJ Levy chases after her niece and nephew -- something that would have been impossible four years ago -- during a recent trip to Disney World in Florida.
EJ Levy chases after her niece and nephew -- something that would have been impossible four years ago -- during a recent trip to Disney World in Florida.
STORY HIGHLIGHTS

* FDA approves Ampyra, the first MS drug of its kind to improve walking speed
* Ampyra is appropriate for all types of MS, although it may not help everyone
* Further studies are needed to see if Ampyra helps with other neurological functions

(CNN) -- The second-to-last time EJ Levy was at Disney World, she used a scooter to navigate the enormous park. Her legs were weak and she suffered from foot drop caused by multiple sclerosis. That was 4½ years ago. On her most recent trip, a few months ago, Levy walked the entire time, thanks in part to a drug approved by the FDA on Friday.

The FDA says the drug, Ampyra (generic name dalfampridine, formerly known as fampridine), is the first MS therapy that is taken orally and the first of its kind to receive FDA approval. It is designed help people with any type of MS improve their walking speed.

The prime of her life

In 2002, Levy was in her 30s and an active hiker and skier with a job on Wall Street and later in San Francisco, California. But her life took a turn when she started stumbling, falling down and dragging her right leg. Her doctor's diagnosis? Secondary Progressive Multiple Sclerosis, a less common form of MS and, as the name implies, one that usually plagues people with the disease after its initial course.

The National Multiple Sclerosis Society defines MS as a "chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves." Symptoms of MS include extreme fatigue, difficulty walking, problems with memory and heat sensitivity.

The most common form of MS is relapsing-remitting , in which people have acute attacks followed by periods of remission. In secondary progressive, however, the disease worsens steadily and there are no acute flare-ups. People with relapsing-remitting may later develop secondary progressive MS.
I was scared of being in a wheelchair. I was scared of getting worse and worse. I had traveled around the world before I got sick, I was super independent.
--EJ Levy, MS patient
RELATED TOPICS

* Multiple Sclerosis
* National Multiple Sclerosis Society

Levy says she lived in the same building as her parents at one point because she needed them to help take care of her. She says she mostly stayed at home, and when she did venture out she usually walked only a block or two with a cane. She relied on a wheelchair for longer distances.

She says she realized she would eventually be unable to walk. "I was scared of being in a wheelchair. I was scared of getting worse and worse. I had traveled around the world before I got sick, I was super independent, " Levy says.

Trying things out

After exhausting the usual MS treatments -- and developing intolerable side effects -- Levy also became frustrated that the treatments were primarily designed for people with the more common course of the disease, and not the secondary progressive course.

Levy's neurologist then discussed the possibility of trying 4-aminopyradine -- a version of the same drug the FDA approved Friday that was available only through compounding pharmacies. Just three days after taking the drug, Levy was able to walk unassisted.

"I never thought I could put my cane away for good," she said.

Now she hopes the same drug that helped her will be able to help other people. She addressed an FDA advisory panel late last year and recommended approval of it.

"It's about quality of life," Levy says.

How it works

Two phase III clinical trials of Ampyra showed 35 and 43 percent of patients experienced, on average, a consistent improvement in their walking speed, increasing it by about 25 percent.

According to the National Multiple Sclerosis Society, even a modest improvement in walking ability could mean that thousands of people could benefit from the drug.

Dr. John Richert, executive vice president of Research & Clinical Programs at the National Multiple Sclerosis Society, says the drug can be used by most people with MS. However, the drug is not for people with a history of seizures or people who have moderate to severe kidney disease.

Richert says approval means patients can now skip the compounding pharmacy and get a consistent, exact dosage in a guaranteed time-released formula, which would lower the risk of getting a toxic dose instead of a therapeutic dose.

"It's likely that further study and clinical practice may help to determine the extent to which the drug may impact other functions, and may also provide hints as to which patients are most likely to respond positively to the therapy," Richert said.

He added that the drug would not help nerves that have been destroyed and emphasized that people should try the drug to see if it works for them.

Ampyra may not work for everyone. "Like any medication, people will have different responses, so they should talk to their doctors about whether it's appropriate to start therapy on Ampyra," according to a spokesperson from Acorda, Ampyra's manufacturer.

Moving with MS

Today, Levy is doing well. She established the not-for-profit organization MS Hope for a Cure, and in three years the organization has raised $1.8 million for research and programs to help people living with MS.

She has also completed several five-mile hikes. But she says she is always conscious of where she steps. She says she occasionally has some weakness in her leg, but that she is thankful for every day: "I don't ever take jumping out of bed for granted."


--- On Thu, 1/21/10, welsh2441 <welsh2441@yahoo. com> wrote:


From: welsh2441 <welsh2441@yahoo. com>
Subject: [multiple-sclerosis ] New to the group
To: multiple-sclerosis@ yahoogroups. com
Date: Thursday, January 21, 2010, 8:47 PM



Hello everyone, I am new to the group....and to

I am newly diagnosed with CIS as of Oct '09. Not sure what to expect. They found one lesion in my C-spine, none anywhere else. For that I am very grateful! Spent end of July in hospital, getting spinal tap, etc. They put me on high doses of steroids. So far, I am not required to take meds, just Vitamin D3 and go back for another MRI this spring. I had experienced tingled in fingers and torso.

At first they thought it was MS, but guess since I only have one lesion I don't "technically" have it at this time. I've heard sometimes though, that they treat CIS with MS injection therapy. Anyone out there have CIS and on injection therapy?

Thanks,


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Postby Jugular » Sun Jan 24, 2010 6:12 pm

This great news! This the first drug aimed at secondary progressive MS and the first aimed at improving nerve function. I can't wait to try it, though I may be waiting awhile here in Canada. Biogen owns the worldwide rights outside the US. They have filed in Europe and in Canada. I hope the reviews go quickly. In the meantime I look forward to reading reviews from patients in the US who try it!
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Ampyra

Postby Jason » Thu Jan 28, 2010 6:48 am

I have been watching this one for 2 years and now we are one big step closer to having it approved in Canada. As the Liberation Therapy seems to only halt progression in SPMS and Ampyra does not stop progression, it seems to be a match made in heavan and it has given me hope again.
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ampyra

Postby ramairdad » Thu Mar 04, 2010 8:12 am

I would like to here from anyone else who has tried this drug and their experiences. I am trying to get my neuroligist to prescribe this. She said I could try it when a pharmacy around here gets it in.
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ampyra

Postby ellen » Mon Mar 22, 2010 5:53 am

Would like to know if anyone has received ampyra through rx channels yet? I've had rx from neuro, blood work done, and am waiting to hear...it has been a little over 1 week. Hopefully, insurance won't pose a problem and will have reasonable co-pay.

Thanks for any feed back,

Ellen
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Postby ramairdad » Mon Mar 22, 2010 8:30 am

I just got off the phone with a pharmacist and insurance will cover this! I'll post when I get the medication and how I do on it.
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Postby SCGirl » Fri Apr 23, 2010 7:11 am

I get my first dose in the mail April 29th. The cost for me was $150 for a 90 day supply. After being tested for CCSVI and finding no stenosis, this is my only hope thus far that I will be able to keep my job. Send prayers!
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Postby LR1234 » Fri Apr 23, 2010 8:29 am

Please let us know how you all do x
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Postby jlccaz » Wed Apr 28, 2010 1:03 pm

SCGirl wrote:I get my first dose in the mail April 29th. The cost for me was $150 for a 90 day supply. After being tested for CCSVI and finding no stenosis, this is my only hope thus far that I will be able to keep my job. Send prayers!


I arranged this with my insurer and Accorda for my PPMS husband yesterday. The drug is not available through most pharmacies. It's direct shipped from Accorda to your home. Under our prescription drug plan it was $45 per 30-day supply (his neuro prescribed 3 months). Accorda has a co-pay reduction program that will kick in for any co-pay over $40, so in our situation, for example, we pay $40, and Accorda picks up the $5 excess of $40.

Our doc also said that although the summary statistics do not look very promising (modest % improvement, for modest $ of people) for those people it does benefit, it's a very significant benefit, and also it seems to help those with symptoms/presentments like my husband's ... so we feel hopeful!
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new drug

Postby caraboo » Thu Apr 29, 2010 1:32 am

Hi all,


I wonder when it will be available in the uk? does anyone know.


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ampyra

Postby ellen » Thu May 27, 2010 8:56 am

Anybody having any walking improvements on ampyra? I've been on it over a month now but have so much knee pain I'm not sure I can give it a good try now.

Thanks for feed back,

Ellen
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Postby SCGirl » Thu May 27, 2010 8:58 am

I have been on it for almost a month now, no improvement thus far...
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Postby lyndacarol » Thu May 27, 2010 4:39 pm

The following segment on Ampyra appeared on the Today Show this morning (Thursday, 5/27/10). I fully expected to find it already posted here, but it isn't. So for your viewing pleasure I am submitting this:

http://today.msnbc.msn.com/id/26184891/ ... 1#37375091
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Postby Lyon » Thu May 27, 2010 4:54 pm

.
Last edited by Lyon on Sun Nov 20, 2011 7:36 pm, edited 1 time in total.
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i have had improvement

Postby leetz » Fri May 28, 2010 9:19 pm

going on month number 2 and ampyra has worked for me with spasticity and walking...the major problem here is that one of the side effects is ms exacerbation...which did happen to me...only i am not sure if it was because i had bronchitis or because of the ampyra...i am still taking the ampyra and have noticed slight improvement thus far and also had an increase in walking speed of 4 seconds...so i like it...
GOD BLESS.... CCSVI treatment Dr. Siskin great doc....symptom's improved for about 3 week's (gait, balance, spasticity) now back to square 1...
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