Ampyra Approved

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Ampyra Approved

Postby LoveActually » Fri Jan 22, 2010 9:50 pm

FYI...

A new drug called Ampyra was approved today to help with walking issues for adults with MS. I don't know much about it but if you just google 'Ampyra', there's a lot of info there.
October 29, 2009 - Dx with RRMS
June 22, 2010 - Dx's changed to Devic's (NMO)
January 4, 2011 - Dx w/Syringomyelia T4-T9, Migraines, and Possible MS (again - long story)
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Postby Algis » Fri Jan 22, 2010 10:35 pm

It seems like Fampridine (4-AP)?

The most common adverse reactions reported by patients taking Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin.


Darn...
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Postby Fred1208 » Sat Jan 23, 2010 2:58 am

Hi everybody,

Ampyra is effectively the new brand name for Fampridine-SR from Acorda therapeutics, which manufactures the product in cooperation with Elan Company.

It will be available in US in March 2010, and I hope very soon in France :)

Here is the information given on the Acorda Website :

Acorda Therapeutics Announces FDA

Approval of AMPYRA(TM) (dalfampridine) to Improve Walking in People with Multiple Sclerosis - Demonstrated by Increases in Walking Speed

First and Only FDA-Approved Therapy Addressing Walking Impairment
AMPYRA Previously Referred to as Fampridine-SR
AMPYRA Expected to be Available by Prescription in March 2010
Acorda Conference Call Today at 5:30 p.m. Eastern Time

HAWTHORNE, N.Y., Jan 22, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA(TM) (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs.

"The approval of AMPYRA marks an important milestone for the many people with MS who suffer walking impairment. Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics, adding: "We are enormously gratified to have achieved approval for the only medication indicated to improve walking in people with MS, and we thank all of the clinicians, people living with MS and medical and patient support organizations who joined in this effort over the past decade. Reaching this milestone underscores Acorda's ongoing commitment to develop innovative therapies for people with neurological diseases."

"Walking impairment affects a large majority of people with MS, and we are very pleased that the FDA has approved a new treatment that addresses this aspect of the disease," said John Richert, M.D., Executive Vice President for Research & Clinical Programs at the National Multiple Sclerosis Society. "Continuing to advance clinical research and expand the range of therapeutic options for people with MS, including treatments for the most debilitating symptoms and challenges associated with the disease, is critical to helping people with MS."

AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. The FDA granted AMPYRA orphan drug status, which will provide seven years of market exclusivity for the drug. In addition, Acorda has several issued patents that cover the formulation and use of AMPYRA.

AMPYRA is administered as a 10 mg tablet twice daily, approximately 12 hours apart. The primary measure of efficacy in its two Phase 3 MS trials was walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25FW), using a responder analysis. A responder was defined as a patient who showed faster walking speed for at least three visits out of a possible four during the double-blind period than the maximum speed achieved in the five non-double-blind, no treatment visits (four before the double-blind period and one after).

A significantly greater proportion of patients taking AMPYRA 10 mg twice daily were responders compared to patients taking placebo, as measured by the T25FW (Trial 1: 34.8% vs. 8.3%; Trial 2: 42.9% vs. 9.3%). The increased response rate in the AMPYRA group was observed across all four major types of MS.

During the double-blind treatment period, a significantly greater proportion of patients taking AMPYRA 10 mg twice daily had increases in walking speed of at least 10%, 20%, or 30% from baseline, compared to placebo. In both trials, the consistent improvements in walking speed were shown to be associated with improvements on a patient self-assessment of ambulatory disability, the 12-item Multiple Sclerosis Walking Scale (MSWS-12), for both drug and placebo treated patients. However, a drug-placebo difference was not established for that outcome measure.

"Walking impairment makes life more difficult for many of my patients," said Dr. Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "With the approval of AMPYRA, we will have the first treatment option shown to improve walking speed in people with MS."

Acorda expects AMPYRA to be commercially available in the United States in March 2010. AMPYRA will be distributed exclusively through a network of specialty pharmacies and coordinated by AMPYRA Patient Support Services. Dedicated and experienced customer care agents will be available to help healthcare professionals process prescriptions, work with insurance carriers to facilitate coverage, and help patients to access benefits available through reimbursement assistance and patient assistance programs.

AMPYRA Patient Support Services can be reached at 888-881-1918 for more information about AMPYRA.

The FDA approved AMPYRA with a risk evaluation and mitigation strategy (REMS) program comprising a medication guide and communication plan. The goals of the communication plan are to inform patients about the serious risks, including seizures, associated with use of higher than recommended doses of AMPYRA therapy, and the change of the established name from fampridine to dalfampridine.

AMPYRA will be marketed in the United States by Acorda's established commercial organization, which successfully launched ZANAFLEX CAPSULES(R) (tizanidine hydrochloride). The Company plans to double the number of field- based sales professionals to approximately 100 by the time of commercial availability in March.

Under Acorda's existing license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (NYSE: ELN), AMPYRA will be manufactured by Elan Drug Technologies using one of their Oral Controlled Release Technologies, the MXDAS(TM) (MatriX Drug Absorption System) technology.

"We are delighted that AMPRYA will now be available to help people with MS. This approval represents another significant milestone in our successful collaboration with Acorda Therapeutics," announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "The approval is the culmination of an enormous amount of work and effort over many years and is the second product in which we have collaborated with Acorda. We hope to find additional opportunities to work together in the future."

Important Safety Information

AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.

AMPYRA is contraindicated in patients with moderate to severe renal impairment (CrClless-than or equal to 50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.

Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo

The most common adverse events (incidence greater-than or equal to 2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.

For full prescribing information, please visit: http://www.AMPYRA.com.

Conference Call

Acorda will hold a conference call and audio webcast on January 22, 2010 at 5:30 p.m. ET. To participate in the conference call, please dial 800-573-4752 (domestic) or 617-224-4324(international) and reference the access code 51443395. The presentation will be available via a live webcast at:

http://phx.corporate-ir.net/phoenix.zht ... ID=2697617

A replay of the call will be available from 8:30 p.m. ET on January 22, 2010 until midnight on February 22, 2010. To access the replay, please dial 888-286-8010(domestic) or 617-801-6888 (international) and reference the access code 14061810. The archived webcast will be available for 30 days in the Investor Relations section of the Acorda website at http://www.acorda.com.

About AMPYRA (dalfampridine)

AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured globally by Elan based on an existing supply agreement with Acorda.
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Postby shye » Sat Jan 23, 2010 6:57 am

a report on someone already using the drug:

http://www.cnn.com/2010/HEALTH/01/22/fd ... index.html
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Postby ElMarino » Sat Jan 23, 2010 8:12 am

But this makes it sound less appealing, from the Royal London blog:

Aminopyridines, a family of compounds to which Fampridine belongs, works by lowering the requirements for axons (the electrical cabling of nerves) by blocking a specific group of proteins on their surface called voltage-gated potassium channels. This makes it more likely for an electrical impulse or action potential to be transmitted across a demyelinated segment of an axon. Although this will improve motor function the effect on sensory and other pathways may make some problems worse, for example exacerbation of pain and increase in the frequency and severity of MS-related positive symptoms (pins & needles, muscle spasms and seizures).
Aminopyridines will almost certainly increase the energy requirements of damaged, vulnerable, demyelinated axons as they will require more energy for repolarization the process by which they get ready to transmit another electrical signal. There is now good evidence that increasing the energy requirements of axons may result in further axonal injury and loss. Essentially this is the theory underlying the use of sodium channel blockers, such as phenytoin or lamotrigine, as neuroprotective compounds in MS; by reducing transmission you reduce the energy requirements and hence protect vulnerable axons.
For these reasons I am wary about the long-term use of Fampridine in MS-related motor fatigue. I am worried that Fampridine may speed up the rate of disability progression. I stand to be proved incorrect on this; we will only find this out by doing clinical trials and following up patients with progressive MS on these medications for long periods of time using standardised methods.
I have posted Hugh Bostock’s videos, from Queen Square, on conduction in a normal nerve and a demyelinated nerve, on YouTube, to illustrate how slow and difficult it is to transmit an electrical impulse down a demyelinated nerve. When you watch the videos please try and imagine how much more effort/energy is required for conduction in demyelinated axons; aminopyridines are the chemical whips that keeps these axons firing.
http://www.youtube.com/watch?v=wLSxS9THnGU
http://www.youtube.com/watch?v=iC9U0Obzhh4


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Postby LisaE » Fri Jan 29, 2010 1:46 pm

I wanted to share an article I wrote on Ampyra/4-aminopyridine which pulls together history of the research and patient stories. I don't know of any other place on the web which has all of this information in one place.

It would be great if folks interested would come read and comment. Obviously I don't participate much here at all, but I do occasionally come to TIMS to catch up on the latest.

Article can be found at AMPYRA™ (dalfampridine) FDA-approved for MS patients; Connie and Melissa share their stories
or http://www.healthcentral.com/multiple-s ... 100/ampyra

BTW, I am the MS blogger at http://brassandivory.blogspot.com/
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Postby donaldjeo » Sun May 02, 2010 11:43 pm

Dalfampridine (Ampyra) extended-release tablets have been approved by the U.S. Food and Drug Administration to help adults with multiple sclerosis (MS) who have trouble walking.
In clinical testing, people who took Ampyra had faster walking speeds that those who took a placebo, the agency said in a news release.

MS is a chronic, often disabling disease affecting the brain, spinal cord and optic nerves. Some 400,000 people in the mcitp United States and 2.5 million globally have been diagnosed with the disease, the FDA said.

The drug, if given at doses higher than the recommended 10 milligrams twice daily, can cause seizures, the agency warned. The most common reported side effects include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, nasal or throat swelling, irregularity, indigestion and burning or itchy skin.

People with moderate-to-severe kidney disease shouldn't take Ampyra, the FDA said.

The drug is marketed in the United States by Hawthorne, N.Y.-based Acorda Therapeutics.[/url]
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