Acorda Therapeutics (Amprya) Recognized by National Organization for Rare Disorders for Contribution to Treatment of Multiple Sclerosis

Acorda Therapeutics, Inc. today announced the National Organization for Rare Disorders (NORD) is recognizing the Company for its efforts to develop therapies for rare diseases. Earlier this year, Acorda received approval from the U.S. Food and Drug Administration (FDA) for AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, the first therapy to improve walking in people with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. The award will be presented tonight at the 2010 NORD Partners in Progress Gala in Washington, D.C

Extension Data Show Dalfampridine (Amprya) Continues to be Beneficial in Multiple Sclerosis

(Posted By: Josi Creek)

New open-label extension numbers of dalfampridine extended release suggest the drug continues to improve walking speed in some patients with no new safety signals.

Presenting at the American Academy of Neurology 62nd Annual Meeting, Andrew Goodman, MD, from the University of Rochester, New York, reported improvements in some people for up to 2.5 years.

Acorda Therapeutics Announces Data on AMPYRA(TM) (dalfampridine) Presented at American Academy of Neurology Meeting

(Posted By: Josi Creek)

Responders to AMPYRA Treatment Showed Improvement in Average Walking Speed Compared to their Average Baseline for Up to 2.5 Years in Open-Label Studies

To read the full story, click HERE.

Dr. Ron Cohen, CEO and founder of Acorda Therapeutics, discusses his company's work on treatments for Multiple Sclerosis.

(Posted By: Josi Creek)

Part 1



Part 2



Part 3

Biogen Idec Strengthens Position as a Leader in Neurology with 38 Data Presentations at 62nd Annual Meeting of the American Academy of Neurology

(Posted By: Josi Creek)

CAMBRIDGE, Mass., Apr 05, 2010 (BUSINESS WIRE) ----Biogen Idec (NASDAQ: BIIB) today announced that 38 company-sponsored platform and poster presentations will be presented during the American Academy of Neurology's (AAN) 62nd Annual Meeting in Toronto, April 10 -- 17, 2010. The AAN Annual Meeting is the world's largest gathering of neurologists. These presentations include data on five compounds that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS), including two approved therapies for MS, TYSABRI(R) (natalizumab) and AVONEX(R) (interferon beta-1a), and three promising compounds in the late stages of development: BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and daclizumab.

To read the entire story, click HERE.

Clinical Benefit of Multiple Sclerosis Drug Discovered

(Posted By: Josi Creek)

Drug approved by the FDA in January, now available in the U.S.

A drug whose clinical benefit in treating multiple sclerosis was discovered at Rush University Medical Center was approved by the Food and Drug Administration on January 22 and is now available in the U.S.

To read the full story, click HERE

"the neuro said he will start me on Ampyra, the walking drug-Im optimistic for that because if it works that would be AMAZING"

(Posted By: Josi Creek)
Hi Stan! When I went to the neuro last week..he also said he will start me on Ampyra, the walking drug when he gets the samples in (probably 4-6 months) I wanted to share this info with our Angels!

I am optimistic for that because if it works that would be AMAZING!!!!

He said that for people like me where the majority of the disease is in the spine it looks very promising.

He said if you just looked at my brain scan you would say I had a mild case of MS, my back is what is disabling me.

He said the ampyra seems to help the nerve conduction to the legs and makes walking less difficult.

He is trying to find a rep to get some samples for me so I can try it for a few weeks first because it will be expensive. He also said there is not a formulary yet but that should be coming to him in a few months.

He did say that the one drawback is that in some people it can cause seizures so that is something to be concerned about.

Anyway, hello and hugs to everyone. Hope it's a good spring for all!

♥ ginny

OUR NEWS EDITOR: JENNIFER LANDRY GAVE THE FOLLOWING IMPORTANT ADVICE GINNY! Click here to go to our Facebook Page & read more comments & advice & our Facebook Friends left for Ginny!

( By Jennifer Landry)

ginny, do not wait for your neuro to get samples. i was involved in a recent webcast put on by the vp's at ampyra and they were very clear that they will NOT be providing samples to dr's. just don't want you waiting for something that's not going to happen. there is a comprehensive patient assistance program to help with the cost of the drug. go towww.ampyra.com and contact them for further info. you need to complete a form and your neuro needs to submit the prescription and they take it from there to determine what your insurance will cover. good luck to you! (((((hugs)))))

Ampyra (the new walking pill) - Acorda Therapeutics Webcast

( Posted by Jennifer Landry)

Acorda Therapeutics, the company that developed and is now marketing AMPYRA (dalfampridine) in the U.S., is hosting a webcast for MS bloggers on Wednesday, March 17 and our own Jennifer Landry has been invited to attend. Acorda’s senior leadership team, including their CEO Ron Cohen (above), are providing an overview of AMPYRA, including the clinical trial data and information on pricing and insurance. Most importantly, they are also taking questions from the attendees.

MS News Channel will be posting updates following the webcast, so stay tuned.

(VIDEO) FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis

"Today is a week since I started ampyra- I can tell a difference with it. With my walking, I don't drag as much"

CLICK HERE TO GO TO OUR FACEBOOK PAGE & READ COMMENTS & (((HUGS)) OUR Facebook FRIENDS LEFT FOR BERLENA!

AND

CLICK HERE TO READ 1000'S OF OTHER STORIES ABOUT OUR 2,700 Facebook FRIENDS LIKE BERLENA'S BELOW:

Hi Stan,
Today is a week since I started ampyra. The first couple of days of taking it, I definitely didn't feel well. I was dizzy and didn't feel like doing anything.

I am feeling better, and I can tell a difference with it. With my walking, I don't drag as much and I'm hoping that as time goes by it will get better.

I called my doctor and spoke with her nurse, and she said that she had received calls from some clients who complained about numbness in their mouth. So far that hasn't happened with me.

I went to an MS Seminar last Saturday, and I was surprised at the number of people who hadn't heard of ampyra and at the number of people who had heard about it, but didn't know the procedure to get it. I was the only one in attendance who had started it.

Ampyra Special Report #1: Cost & Process for getting the drug

(Posted by Jennifer)

JENNIFER, ONE OF OUR NEWS EDITORS ON www.MSnewsChannel.com WAS INVITED TO A SPECIAL PRIVATE WEBCAST ON AMPYRA! I POSTED INFO ON THIS WEBCAST YESTERDAY:

CLICK HERE TO SEE THE ORIGINAL STORY, ALONG WITH QUESTIONS AND ANSWERS ABOUT AMPYRA

HERE'S JENNIFER'S 1ST REPORT:

Special Report #1: Ampyra Cost & Process for getting the drug

Hi All, I learned so much about Ampyra and can't wait to share it all with you. The most important and timely information I thought you would appreciate is the cost of Ampyra and the process by which you can obtain the drug. If you are on the fence about trying it, stay tuned, I have lots of answers to questions you may have. If you have already decided it's something you want to try, I'll tell you how.

The cost of the drug is $1,056 for 60 pills, a 1 month supply. This cost incorporates many factors, the cost of development, trials and a 20 year journey to get it to market; the perceived value of what it offers to the ms community; and a portion of the design and manufacture of future drugs/trials for ms patients. All of these correlate to what Acorda feels is a fair cost to consumers.

That being said, Acorda is committed to making Ampyra available to every patient that wants to take it.

CLICK HERE TO SEE THE FULL STORY ON OUR FACEBOOK PAGE

"they are processing my prescription for Ampyra, the 'walking pill'-Im excited-Its $1000 per month & covered by my insurance"

CLICK HERE TO GO TO OUR FACEBOOK PAGE & READ COMMENTS & (((HUGS)) OUR Facebook FRIENDS LEFT FOR BERLENA!

AND

CLICK HERE TO READ 1000'S OF OTHER STORIES ABOUT OUR 2,700 Facebook FRIENDS LIKE BERLENA'S BELOW:


[Berlena Spencer-Staton]
Stan, I mentioned before about the "walking pill". As you know it's been approved by FDA, and I did the form and my nuero faxed it to the company. I was given a prescription to have blood work done to check my kidney function, but luckily I had just had blood work done, and checking was kidney function was one of the test, and it was normal. Tel Drugs just called and they are processing my prescription and I should hear from them about delivery in a few days. I'm excited, and really hopes it helps because I'm going on vacation next month. I'll keep you posted.

[Stan Swartz]
Is your insurance covering it? tell me more about it all!

[Berlena Spencer-Staton]
It is $1000 per month and it is covered by my insurance. As soon as it was approved, I received an e-mail from my doctor, I had to go to www.ampyra.com and print and fill out a form and fax it to her. She in turn sent it to the company, and I don't know the procedure the company itself does to approve it, but they contacted my doctor and Cigna Tel Drug and my doctor approved a 3 month supply at $18 per prescription,which is my co-pay. Here's the link Stan:

www.ampyra.com

"please ask the Angels to tell me everything they know about Ampyra-the new drug for walking that was just approved by the FDA"

CLICK HERE TO GO TO OUR FACEBOOK PAGE & READ COMMENTS & (((HUGS)) OUR Facebook FRIENDS LEFT FOR KARIN!


AND CLICK HERE TO READ 1000'S OF OTHER STORIES ABOUT OUR 2,700 Facebook FRIENDS LIKE KARIN'S BELOW:

I want to take Ampyra and I was wondering if you could give me some info on it Stan. And would you please ask the Angels to tell me everything they know about Ampyra! It is the new MS drug for walking that was just approved by the FDA

I asked my Neuro and he didnt know anything! All he said to me was that he didnt think insurance would cover it and that it was $1000 per month so he wasnt too interested in it because none of his patients could afford it.

But I read the post you made earlier from one of the Angels who said that her insurance is going to pay for her Ampyra! SO I DONT UNDERSTAND WHY MY NEURO SAID THAT! I love my neuro Stan!!

Love & xoxoxo

Karin

"I'm going to do oral drug called amypra for walking in a few weeks...hopefully will see maybe a little improvement""

CLICK HERE TO GO TO OUR FACEBOOK PAGE & READ COMMENTS & (((HUGS)) OUR Facebook FRIENDS LEFT FOR CHRIS!

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hi stan, how are you?

Tysabri is a good idea..have been on the shots and all they did was make me worse..

the rebif messed up my hands real bad.:( my neuro said i have PPMS..im starting to feel it is headed towards PRMS..the worst kind..all i do is relapse!

never had a remission at all.

goin to talk to my neuro next month about Tysabri..my disease progression is bad..mri is showing that..

also I'm still going to do that oral drug called amypra for walking in a few weeks..hopefully will see maybe a little improvement..it for sure is only a symptom treatment..

i love your page on here and on myspace..:) lots of loving and caring angels you have..:) wonderful sites..:)

wishing you the absolute best always!

chris

Drug Information About Amprya

Last Updated: March 18, 2010

(Posted By: Josi Creek)

Manufacturer:

Acorda Therapeutics

Pharmacological Class:

Potassium channel blocker

Active Ingredient(s):

Dalfampridine 10mg; ext-rel tabs.

Indication(s):

To improve walking in patients with multiple sclerosis (demonstrated by an increase in walking speed).

Pharmacology:

In patients with multiple sclerosis (MS), the functioning of nerve fibers in the central nervous system degrades over time, causing, among other symptoms, difficulties in ambulation. Research has shown that 64–85% of people with MS have difficulty walking, and 70% of those affected report it to be the most challenging aspect of their disease. Within 15 years of a diagnosis of MS, 1/2 of the patients often need help walking and, in later stages, up to 1/3 are unable to walk.

Dalfampridine, which was previously known as fampridine, is a broad spectrum potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels. The mechanism of action in humans has not been fully elucidated.

Read more about it here.

Acorda deals MS med direct to patients

(Posted By: Josi Creek)

Acorda Therapeutics is taking a novel approach to selling Ampyra, a treatment for multiple sclerosis. Designed to help MS patients walk, the drug won't be distributed through drugstores or even through doctors' offices. Patients will order it directly from the company.

To read the full story, click here.

Acorda Therapeutics Announces Filing of Patent Extension Applications for AMPYRA(TM) (dalfampridine)

HAWTHORNE, N.Y., Mar 22, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. today announced that the Company has submitted applications to extend patent protection for AMPYRA(TM) (dalfampridine) Extended Release Tablets, 10 mg to the United States Patent and Trademark Office (USPTO).

AMPYRA was approved by the U.S. Food and Drug Administration (FDA) on January 22, 2010 and has seven years of exclusivity in multiple sclerosis (MS) based on orphan drug status, which has been confirmed by the FDA. Acorda has applied to extend two AMPYRA patents listed in the FDA Orange Book based on provisions in the Hatch Waxman Act that allow for up to five additional years of patent protection based on the development timeline of a drug. These patents currently expire on December 6, 2011 and July 30, 2013. If both are granted, the Company will need to select one patent for extension.

Read the full story here.

"they are processing my prescription for Ampyra, the 'walking pill'-Im excited-Its $1000 per month & covered by my insurance"

Berlena Spencer-Staton had a recent conversation with Stan about starting Amprya. She seems excited.

[Berlena Spencer-Staton]
Stan, I mentioned before about the "walking pill". As you know it's been approved by FDA, and I did the form and my nuero faxed it to the company. I was given a prescription to have blood work done to check my kidney function, but luckily I had just had blood work done, and checking was kidney function was one of the test, and it was normal. Tel Drugs just called and they are processing my prescription and I should hear from them about delivery in a few days. I'm excited, and really hope it helps because I'm going on vacation next month. I'll keep you posted.

[Stan Swartz]
Is your insurance covering it? tell me more about it all!

[Berlena Spencer-Staton]
It is $1000 per month and it is covered by my insurance. As soon as it was approved, I received an e-mail from my doctor, I had to go to www.ampyra.com and print and fill out a form and fax it to her. She in turn sent it to the company, and I don't know the procedure the company itself does to approve it, but they contacted my doctor and Cigna Tel Drug and my doctor approved a 3 month supply at $18 per prescription,which is my co-pay. Here's the link Stan:

www.ampyra.com

Stan can be contacted at http://www.facebook.com/StansAngels

WOW!!! NEW TREATMENT APPROVED (Ampyra-formerly known as fampridine) "FDA approves drug for MS"

(Posted By: Josi Creek)


FDA approves drug for multiple sclerosis

(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.

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.

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.

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."

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.

Read the full story here.

To contact Stan, please visit him on facebook at http://www.facebook.com/StansAngels

Ampyra available for multiple sclerosis patients

(Posted By: Josi Creek)

On March 1, 2010, Ampyra was made available, by prescription only, in the United States.

Acorda Therapeutics has made available Ampyra (dalfampridine extended-release tablets) as a treatment to improve walking in patients with multiple sclerosis (MS). Ampyra is indicated for use in all types of MS, and can be used either alone or with existing therapies, including disease-modifying agents.

Ampyra is available in a 10mg dosage strength.

For more information call (888) 881-1918 or visit www.ampyra.com.

Source: http://www.empr.com/ampyra-available-for-multiple-sclerosis-patients/article/164759/

The History Of Amprya

Amprya is a new drug that is said to improve mobility for those suffering from multiple sclerosis. Many years of research have gone into the development of this amazing drug, which finally made its way into the market in March 2010 after it's FDA approval on January 22, 2010.

THE BACKGROUND


1969-1990:
Early research out of London (1969-1983) included published papers related to conduction, demyelination, ion channels, 4-AP and multiple sclerosis. The first clinical study of 4-AP and visual function in MS was published in 1983. See J Neurol Sci. 1983 Aug-Sep;60(3):353-62. Early research from Yale and Brown Universities (1977-1994) include several studies of demyelination and aminopyridine in multiple sclerosis and spinal cord injuries.


Research in Chicago (1974-1991) focused on the use of 4-AP in treatment of MS symptoms. Three small clinical trials performed at Rush Multiple Sclerosis Medical Center in Chicago were published between 1987-1991 in which researchers observed clinical benefits while also comparing oral vs. intravenous delivery of the compound. See Ann Neurol. 1987 Jan;21(1):71-7. See Ann Neurol. 1990 Feb;27(2):186-92. See Neurology. 1991 Sep;41(9):1344-8.


1990-1997:
In 1990, Elan Corporation obtained the Know-How related to fampridine (4-aminopyridine) for symptomatic treatment of multiple sclerosis from Rush-Presbyterian Hospital in Chicago. Research continued in Amsterdam (1990-1996) where several clinical studies were conducted including the first large trials of 4-AP in MS looking at its broad effects on disability (EDSS) and long-term safety and efficacy (during one trial two patients had seizures and one developed hepatitis). See Ann Neurol. 1992 Aug;32(2):123-30. See Clin Neuropharmacol. 1993 Jun;16(3):195-204. See Arch Neurol. 1994 Mar;51(3):292-6.

In 1994 and 1996, Elan obtained the patents to the sustained-released technology for Fampridine-SR (slow-release fampridine/4-aminopyridine) which had been developed by Joseph Masterson and Michael Myers. Elan also sponsored clinical research at the University of Maryland, Baltimore (1990-97) as well as the very first clinical trials of Fampridine-SR in multiple sclerosis. SeeNeurology. 1997 Apr;48(4):817-21.


1995-2004:
In March 1995, Dr. Ron Cohen founded Acorda Therapeutics, Inc. to develop therapeutic products for spinal cord injury and other central nervous system disorders. Immediately, Acorda obtained the rights to develop fampridine for therapeutic use in spinal cord injury from the Canadian Spinal Research Organization (CSRO). In January 1997, Acorda entered into another licensing agreement, this one with Elan, to develop fampridine-SR for treatment of spinal cord injury.


In April 1998, Acorda and Elan entered a joint venture and formed the MS Research & Development Corp (MSRD). MSRD turned around and licensed research and development technology from Elan to develop Elan's proprietary oral sustained release formulation of fampridine for the treatment of multiple sclerosis. MSRD was permanently terminated in September 2003 when Acorda entered into agreements with Rush and Elan, terminating the Rush license to Elan with mutual releases. In the process Rush granted Acorda worldwide license to the Know-How and Orphan Drug Designation to fampridine for treatment in MS.


In December 2000, Accorda had announced they would initiate a Phase II trial of Fampridine-SR in MS (MS-F201). Results of that dose-ranging study were presented at the Sept 2002 ECTRIMS meeting but weren't fully published until 2007. See Mult Scler. 2007 Apr;13(3):357-68. Epub 2007 Jan 29. In April 2004, Acorda announced that Phase III clinical studies of Fampridine-SR in spinal cord injury did not produce the desired statistically-significant results, but that positive data from a second Phase II trial in MS (MS-F202) confirmed results from previous Phase II trials.


2005-2008:
Acorda Therapeutics turned to developing Fampridine-SR for use in MS announcing in May 2005 that they had worked out a Special Protocol Assessment (SPA) with the FDA for their phase III trial design. On April 7, 2006, Acorda’s President and CEO Ron Cohen rang the opening bell on Wall Street to celebrate their successful IPO launch. In September 2006, Acorda announced positive Phase III results (MS-F203) which were later presented at the AAN meeting in May 2007 and the ACTRIMS meeting in Washington, DC in June 2007. Results from this 1st Phase III trial were finally published in The Lancet in February 2009. See Lancet 2009; 373: 732–38.


In January 2008, Acorda announced positive data from a successful QT safety study which is required by the FDA for all new drugs seeking regulatory approval. In June 2008, Acorda announced positive results from the 2nd Phase III study of Fampridine-SR in MS (MS-F204). Results from this second Phase III trial have yet to be published.


2008-2010:
In March 2008, Acorda announced the results from a commissioned survey focused on Mobility and Quality of Life. Also in the spring of 2008, Acorda sponsored several MS Walks throughout the country. Walk MS is one of the larger fundraisers for the NMSS. In conjunction, Acorda launched the non-branded outreach website titled “I Walk Because” which features videos and profiles of MS patients and Walk MS participants.


In January 2009, Acorda submitted their New Drug Application (NDA) to the FDA for approval of Fampridine-SR (which is now called AMPYRA). The FDA Central Nervous System Advisory Committee held a meeting on October 14, 2009 to evaluate the clinical significance of AMPYRA (referred to as Amaya or Ampriva at the time) for improving walking ability in MS patients. Detail regarding the various clinical trials and data leading up to this approval can be found in the 177-page document (pdf) prepared for the FDA Committee meeting.


Data from the Phase III trials suggest that only some patients may derive a clear benefit and selectivity in responsiveness might be related to the proposed mechanism of action where only some patients would be expected to have axons (nerves) susceptible to the drug effects at any given time.


The FDA Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use. But due to the increased risk of seizures associated with the drug and concerns about the use of Fampridine-SR in patients with renal impairment, the Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval. Lower doses are not expected to be available for at least two or three years, if at all.


On January 22, 2010, FDA announced that they had awarded marketing approval for AMPYRA™ (dalfampridine, 10mg extended release tablet taken twice daily) as a treatment to improve walking in MS patients. AMPYRA™ will be marketed in the United States by Acorda Therapeutics and out of the US by Biogen Idec who purchased those rights last June 2009.

Ampyra: A New Medication to Improve Walking - National MS Society

Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA(TM) (dalfampridine)

--Co-Pay Program Implemented To Help Manage Out-of-Pocket Expenses

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the wholesale acquisition cost (WAC) for AMPYRA(TM) (dalfampridine) Extended Release Tablets will be $1,056 per 30-day supply (60-count pill bottle), an annual cost of $12,850. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is expected to be available in March 2010.

Acorda is launching a comprehensive set of services to ensure broad access to AMPYRA for people with MS, including patient assistance and co-pay programs that will be open as soon as AMPYRA is commercially available.

Read the full story here.

Elan Drug Technologies Welcomes the NDA Approval of MS Drug AMPYRA™ (Dalfampridine) Extended Release Tablets

DUBLIN, Ireland--(BUSINESS WIRE)--

(Posted By: Josi Creek)

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA^™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA^™ will be marketed in the U.S. by Acorda Therapeutics (NASDAQ: ACOR).

Using Elan Drug Technologies MXDAS^™ technology, AMPYRA^™ was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced. AMPYRA^™ is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS^™ technology.

Read the full story here.

Biogen Idec Issues Statement on U.S. Approval of AMPYRA™ (dalfampridine)

(Posted By: Josi Creek)

Biogen Idec (NASDAQ: BIIB) today issued the following statement regarding the United States (U.S.) Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. The U.S. FDA approval was granted on January 22, 2010.

AMPYRA will be marketed in the U.S by Acorda Therapeutics, Inc. (NASDAQ: ACOR). AMPYRA is an extended release tablet formulation of the investigational drug dalfampridine (4-aminopyridine and called fampridine outside the U.S.). Biogen Idec will commercialize fampridine as a prolonged release tablet in markets outside of the U.S.

Read the full story here.

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stan