I have been on the compounded 4-AP for about a year and feel that it has had a beneficial effect on my walking speed. The tolerable dose for me is 10mg, taken in 5mg increments twice daily. I too can feel the difference when I delay my second dose. I find concerning the potential cost of Ampyra. Given my positive history with 4-AP, I would absolutely take Ampyra if the cost were not prohibitive, but there's a big difference between paying less than $40 a month and the donut-hole amount I would have to pay for the new drug; that is, assuming Part D even covers this.
Once again, Lisa, you have outdone yourself in presenting us with valuable information prepared in a clear and thorough manner.
Hi Judy,
Another positive 4-AP story. :) I'm sure that Acorda will be doing everything they can so that insurance companies and Medicare cover this drug. Whatever wheeling-dealing needs to be done, I'm sure that they're on it. It will be nice, though, to see what their plan is for helping through the donut hole. Only good thing I see regarding the donut hole is that once you get out of it, prescriptions cost much less.
I did read a mention that Acorda is working on a 5mg dose, but would not be seriously getting that program going until after the 10mg dose (twice daily) has taken hold in the market for at least 2-3 days. I think that I read mention that FDA suggested working on a 7.5mg dose. Acorda was clear though (in the report I read) that for right now it is 10mg only.
I'm so glad that you found this article informative. I was afraid that it would be too long for most readers (was hoping it would fit on fewer pages). But I also felt that not all of this information had been brought together in one place. Thanks so much for the kudos.
Great job on the article, Lisa. You have provided a great deal of background information and many helpful links. I am happy to be able to pass this on to other MSers who are not yet aware of the FDA approval.
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Hey Connie,
Thanks so much for sharing your story. As you can see in the comments here, lots of folks I didn't even know were using 4-AP are giving it their thumbs up. Sounds like folks will be interested in trying Ampyra as long as the out-of-pocket price isn't prohibitive. Right now it's just a wait and see.
Thanks for spreading the word. I hope that this reference will be useful for many folks looking for complete information. If there is anything I missed, I also hope that folks will let me know.
I found that if I tried to get over 15 mg of 4AP, I became very enraged by the smallest frustration. 4AP was so effective for increasing my endurance and lessening my fatigue that I kept trying to increase the dosage. I finally gave up because at doses over 15mg
I became so irritable. Now, I believe 4Ap is causing behavioral and mood disturbances even at the low 15 mg dosage. After I developed a rash, I looked up rash and aminopyridine on the Internet. I found that aminopyridine was used as a pesticide from a 2000 CDC report. Aminopyridine the pesticide cause behavioral and mood disturbances. I experienced adverse psychiatric events when I took Provigil. Please watch for behavioral and mood disturbances when you take this drug. Not everyone has them when they are on Provigil but some do. Just watch for the same side effects with this new drug. I hate to go off it but I feel that it is causing me to be emotionally labile.
That's so interesting and very informative. I did read that one clinical trial participant dropped out because of anxiety which was relieved when they stopped taking Ampyra, then returned when they started again.
I've heard other MSers talk about the psychiatric side-effects of Provigil which they experienced before Cephalon had to add that to their warning labels. I've not experienced that side-effect of Provigil before, but I do believe that the MS has caused me to become more anxious on the mental health side of things. I've noticed definite changes in the past year in the mental health department.
That's a tough choice - feeling the benefits of strength and less fatigue or watching out for signs of mental health issues and neuropsychiatric responses. Regarding the dosage, I wonder if the special proprietary sustained-release formulation of Ampyra would make it so that you could tolerate 10mg twice daily? As you can see in a comment I left above, Acorda does not plan to introduce a lower dose anytime soon.
I wonder if Acorda even did a survey of all the compound pharmacies in the country to see if they could get an accurate idea of just how many MS patients are really using smaller doses? Now that would be an interesting question for the CEO to answer.
So what do you think you might do? Stick with what you are doing which seems to be effective (although is carrying increased side-effects for you) or try switching to the new Ampyra? I'm just curious.
I also wanted to say that with any newly approved drug, we will learn (hopefully) of more real life side-effects people might experience. The amount of MS patients involved in the two Phase III trials really is small (350 on fampridine I think, with perhaps some switching to drug in the extended portion of the trials). Also, more information to watch for in the future.
Thanks for the responses. I went off 4Ap. I meant to mention that. There's no way I could tolerate the increased anxiety and anger I was feeling. And I had the rash as well to deal with. I notice that the rash is gradually going away. As to why I would take 4ap .. I couldn't make it through the day without it. And now I am faced with the same problem. I'm much calmer. I feel I meeting myself again for the first time in months. I also seem to have lost a constant throbbing headache that i thought was an MS headache. It never went away. But, I really am scared because I notice a real drop in my strength and my endurance. I go to see my neurologist tomorrow. I hope that she is more open to listening to me than she was several days ago. Thanks again for your comments. I just want everyone on this drug to watch for unusual anxiety, feelings of anger that don't seem reasonable, and extreme irritability. It may be the aminopyridine or the new formula.
This sounds incredibly frightening! How could you put that into your body?
Validation of fears is an important part of our community. I haven't tried 4-AP and don't even know if my neurologist does prescribe it for folks. However, that is something which clinical trials and FDA approval will help in the acceptance of a 'new' approach to treating symptoms.
When I spoke with the CEO of Acorda back in the summer of 2008, I mentioned that baclofen had truly helped my spasticity and thus my mobility. (I think that sometime in the past, 4-AP was thought to help with spasticity but testing that certainly was not included in these trials.) He freely admitted that I might not want to switch or that Ampyra might not be right for me. Only a patient and their neurologist can make that determination.
Ok, so I seem to be asking all the 4-AP folks. Do you think that you might stick with the compounded version or switch to Ampyra? Inquiring minds want to know. :)
I just renewed my RX of 4-AP, except I increase the dose to 10 mg twice a day. I think I respond better to the 5 mg capsule taken 4x/day. This way, if I'm busier in the a.m., I can take 3 spread out in the morning and take 1 more in the afternoon. If I'm having a regular day at home, I can take two 5mg in a.m. and two more in p.m. I guess, as it goes with MS, I never know how I'm going to feel each day. In conclusion, I'll say that due to the uncertainty of how I will feel each day, I like to have more control over how small or large each dose is. I hope I am not too confusing. Maybe I'm confused.?.?
Hi BigCthenMS,
Sounds like you are very much NOT confused and are taking control of how you approach each day. Flexibility is often needed with this disease.
I would equate what you are doing with 4-AP (in 5mg increments) to what I do with gabapentin taking what I need in response to how my body has been feeling lately. As long as the total dosage doesn't exceed the recommended limits, it sounds like a great plan FOR YOU!!
Thanks for sharing more about how you are taking control of your treatment. :)
i've been taking fampridine (4-ap) for over a year. i get it from a compounding pharmacy, who makes it up fairly cheaply. i had heard there was a "SR" version in the works, and i would much rather take one every 12 hours instead of 2 every four hours, with a max of 6 per day (i'm told there is a risk of grand mal seizures taking any more than that), but i am certain Ampyra will be more expensive, and i sort of feel bad about giving my money to a big drug company over a small compounding pharmacy. no real dramatic results, but i think it is helping over-all energy levels.i'm still on the fence about ampyra.
Stephen,
Help with overall energy is a good thing. Yes, there is a much greater risk of seizure at higher doses. The SR version is supposed to help that, but it certainly will be much more expensive. The idea of supporting the compounding pharmacies sounds nice. I've had to get medicines for my cats at a local compounding pharmacy here. They have my respect.
i have been on ampyra now for about 3 weeks. when i first started it, i of course had to stop the 4-ap (to avoid overdosing) and any doubts about whether or not 4-ap was helping were instantly dispelled. the SAME DAY i stopped taking it, my walking was dramaticaly worse. it's gotten better since, but i always come back to who knows why any of the things that happen to us ms'ers happen. is the increased fatigue/difficulty walking from the ampyra, or the cytoxan, or both? or the clonazepam. or some combination. or just the natural progression of the disease?
to answer your question, i'm taking the standard 10mg every 12 hours.
Great Job Lisa and company!
I have been on 4AP for a little over two years. It has really made a difference in my life. My foot drop was getting bad and I just did not feel like putting in the effort to go anywhere by myself. When I started the 4AP within a week I wanted to go and do...my independence was back.
The only problem I ever had from 4AP was the delivery of the drug....it seemed sometimes I would get a good boost from a capusule while other times it felt like I had not taken one...such as it is with compound drugs.
I have already placed a call with my doctor...so she is ready! I am so grateful for the people, Melissa, who have gone thru the trials and shared their experiences.
lisa thanks for all the great info. I have been using compounded 4-AP for almost a year. I have noticed some benefit with my walking and do notice that when I don't take it I walk less well.
I'll probably conyinue with the compounded 4-AP as I see no huge difference in the chemistry but a huge difference in the price. I could re-evaluate this position if I hear of better results with people using Ampyra.
It's sad that it will be so expensive and out of reach by many who suffer with MS but that is out of our control. I do hope it works for most.
Again thanks for a great article.
Hi Bombi,
Thanks for coming by and leaving a comment. It seems that price will be a big issue. I am one patient who, because of being self-employed and having an individual insurance policy (as opposed to a group policy), will not have the drug coverage to pay for this at almost any price. But it's not like I'm using 4-AP anyways.
I like hearing from patients who are likely to continue getting the compound form. It provides balance to the discussion. Thanks.
Hi Lisa and all, delighted to see this. I started 4AP this past November and have noticed I can walk further than before! I still must have my stick as an aide, and I still can't go walking around my neighborhood but can actually meander around on short trails with my dog.
As for choosing between Ampyra and 4AP, I'd love to go on Ampyra because I've heard it's far more stable and also effective, but cost will be the deciding factor. If my insurance doesn't cover it, and if I have to pay a higher monthly cost than for 4AP, then I'm afraid the decision is made for me. MS is already an expensive disease, even with insurance, what with the other drugs, MRIs, etc.
Hi Lori,
Good to see you. Also very good to hear that 4-AP is helping you to get around more easily. Going on short meanderings with the dogs sounds very nice. Good for you.
You're right, there is already so much cost involved with having this disease that adding on more just seems oppressive. Last summer I estimated how much the annual cost for just maintenance care was while having MS and RA. It was in excess of $55,000 and that was before I started using Rituxan (crazy expensive, too).
It's hard to justify extra costs sometimes, even if there is a noticeable benefit. At least that's something I personally struggle with.
i greatly appreciate this in-depth article and the links provided by connie on the plm network. since i take avonex, ldn is not an option for me. walking is taxing at best and i need to buy a cane before i go away in three weeks. in my 40 years as a type I diabetic, i've had about half a dozen periods of seizure-like activity (one blog called them pseudo-seizures because they're not produced by the same mechanics in the brain). with all the press about seizures and 4-ap as well as ampyra, i don't know if i qualify to take these drugs. can you provide any insight?
Hi Kathryn,
Thanks for swinging by from PLM. Sounds like you might be headed off for a trip; I hope you have a great time.
The warnings on the label for Ampyra clearly say that this drug should not be used in persons with a history of seizure. I don't know the mechanics at work in seizures associated by hypoglycemia in Type 1 diabetes, but my understanding is that Ampyra lowers the threshold for seizure activity.
This is something to discuss with both your neurologist and your endocrinologist. This is a risk I personally might not be willing to take, but then again I am not you and do not live in your shoes. :)
I do hope that the cane works out well for you in your upcoming adventures. And thanks for the comment and question.
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the wholesale acquisition cost (WAC) for AMPYRA™ (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.
“AMPYRA is the first medication indicated to improve walking in people with MS, one of the most debilitating challenges associated with the disease. Acorda’s goal is to ensure that cost is not a barrier to any person with MS who may benefit from this important medication, regardless of their level of income or healthcare coverage,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “To that end, our assistance programs account for people who are unable to afford their medications but whose income or healthcare coverage often exclude them from other patient assistance programs. And regardless of income, people with private insurance can benefit from our co-pay program, wherever allowed by law.”
AMPYRA Patient Support Services
Acorda has established AMPYRA Patient Support Services, a dedicated resource for healthcare professionals and people with MS. Experienced customer care agents will be available to help healthcare professionals process prescriptions, work with insurance carriers to facilitate coverage, and direct patients to available assistance programs.
The AMPYRA patient assistance program is being managed by a third party organization with extensive experience in coordinating patient benefits. Patients who meet income and other requirements, regardless of their insurance status, may receive AMPRYA at no cost. This may include Individuals who have limited healthcare coverage.
Acorda has also put a program in place to help individuals with private insurance manage their co-payment costs, where allowed by law.
Healthcare professionals and people with MS can contact AMPYRA Patient Support Services at 888-881-1918 from 8:00 a.m. to 8:00 p.m. Eastern Time for more information about AMPYRA, and to learn more about the patient assistance and co-pay mitigation programs.
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 (CrCl≤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 ≥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 and Medication Guide, please visit: www.AMPYRA.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 a supply agreement with Acorda.
I called just now and although all the details haven't been worked out (so I'm told), here is what I learned. There will be two types of programs:
1. the "copay mitigation" program which is only for patients who have commercial insurance. The patient would be automatically enrolled if their copay is greater than $50/month. If your copay is $40, you do not qualify for this assistance.
How would patients be automatically enrolled? All prescriptions will go through their centralized specialty pharmacy program/insurance benefits center. You can't simply take your prescription to your neighborhood Rite-Aid and will only be able to get it mail-order in one-month supplies.
2. the "patient assistance" program for uninsured or underinsured patients which is INCOME-BASED!! and to be administered by a 3rd party. The name of the 3rd party isn't being released, but the woman I spoke with said that NORD (national organization for rare disorders) "didn't ring a bell." She couldn't tell me about the income requirements (yet to be determined?) nor if financial resources would be taken into consideration (such as is the case with the Copaxone program administered by NORD with which I am intimately familiar).
[In my experience with NORD, an income of 250% FPL and about $30K in savings meant that I was expected to be able to 'afford' $10K for the copaxone which NORD didn't provide. Later I discovered that it took an income of less than 200% and less in the bank to qualify for the full assistance. And this for a medication which costs about
$30K now.]
Residents of Massachusetts will not be eligible for the copay program, but might be eligible for the assistance program IF they are uninsured.
No information yet for Medicare/Medicaid beneficiaries. It will depend upon formulary inclusion and other undetermined factors. Forgot to ask about VA beneficiaries.
The biggest disappointment: NO SAMPLES TO NEUROLOGIST OFFICES!!!! That was the only way I was even going to try this if my neuro and I thought it might be helpful.
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I have been taking 4AP for about 3 years and I believe it makes a difference. I started with 20MG, then increased to 30MG and then 40MG and then BAM! I had a seizure. Today I take 20MG (10MG twice a day) and I think it helps. Although 4AP is not terribly expensive, insurance would not pay for it bgecause it was not approved for MS. Now it is. Hurray!
Also, I no longer have a problem with birds resting on my head and shoulders.
Thanklls for the great article.
Michael
Hi Michael,
So glad that those birds don't bother you much anymore!! LOL. Very good to hear that 4-AP has been helping you. I've heard the same thing many times from folks who use the compound form. Sorry to hear about the seizure, but it sounds like it was dose-related and didn't happen again.
I'd be curious to try Ampyra (although I have a pseudo love/hate opinion of the drug company involved). Alas, unless they are designing a hefty sampling program, I will not be able to try it due to the assumed cost.
At a $1500 cap for prescription coverage, just my most important 5 generic medications, minus the amount I pay for a deductible and copays for those 5 prescriptions, uses up every cent of that $1500. However I have worked out a system where I use RXOutreach as much as possible so that I can save precious drug coverage dollars for other things throughout the year.
But in the meantime, I'll put you on my mental list of those eager to make the switch. Won't be long now.
Michael
I noticed that you went from 20mg to 40mg. My neuro said I should go up to 30mg since I wasn't having much result as long as I maintained no less than 130 lbs. I have been reticent to go up to 30...did you have luck with 30 and pushed the envelope to 40?
Yes. I was fine at 30 mg. But to be safe, we kept it at 20 mg. BTW, the prescribed dosage for Ampyra is 20 mg. Maybe there is something to it. ( :>
I tried the 20 but told my neuro that it didn't seem to be doing anything...she has been prescribing this for years through one compounding pharmacy...so she suggested 30 based on her other patients as long as I am 130lbs....well now I'm 126...does that count? (I started the Swank diet about the same time) Of course I don't want a siezure. I was told to take 1 a day for 2 weeks then 2 a day for 2 weeks then 3 a day...I stopped at 2 a day and am "chicken" to go up to 3. Will 126 vs 130 make a difference? Like with my Avonex after 6 years...is it doing anything at this point or not...the walking mobility I have is it a bit ok because of this and if I get off it will it really decliine? I know I need to figure this out myself but it great to communicate with someone who has been here...thank you.
Hi, I tried 4x5 mg 4-AP three days with no effect. Is this enough time to feel a benefit?
For my opinion a Kalium-Channel blocker must be effective suddenly, or you are a non-responder. Is this right????
Regards UWE
I don't what to tell you because I don't know the answers. I was at risk because I had a sewvere seizure disorder as a child. In other words, I was prone to having seizures. I never heard or had any discussions about weight, but I wegh a bit more than you To me, it sounds like your doctor is on top of it and that's a good thing.
Be well,
Michael
The compounded aminopyridine (same active as Ampyra) only runs about 30.00 to 45.00 a month.
It's such a hassle getting financial assistance for Ampyra. My husband started it in late November. To find out in the new year. The copay would be 362$ and some odd cents. We can't afford that. It's been a battle for weeks to get help. All this time I would talk to people at Ampyra. No one says a word about the financial forms. To show your income etc. Today 3 weeks later I am told he has to fill forms out. I said where are the forms. Can I print them out online and fax them back to someone. They tell me to call this number on Monday. It will take Ampyra that long to send over a request of something or another. But would not tell me where online to print the forms out. So I can get started on filling them out for my husband. His writing is not so good these days with the MS. So I fill out all his forms for anything. All he does is sign where it says to.
It's such a hassle getting financial assistance for Ampyra. My husband started it in late November. To find out in the new year. The copay would be 362$ and some odd cents. We can't afford that. It's been a battle for weeks to get help. All this time I would talk to people at Ampyra. No one says a word about the financial forms. To show your income etc. Today 3 weeks later I am told he has to fill forms out. I said where are the forms. Can I print them out online and fax them back to someone. They tell me to call this number on Monday. It will take Ampyra that long to send over a request of something or another. But would not tell me where online to print the forms out. So I can get started on filling them out for my husband. His writing is not so good these days with the MS. So I fill out all his forms for anything. All he does is sign where it says to.
Carol,
I'm sorry to hear that Acorda (makers of Ampyra) has not made it easy to get the financial assistance which your husband needs in order to pay for Ampyra. The information telling patients to call their Patient Support Services line (1-888-881-1918) is somewhat buried on the website. I don't see that they have made any forms downloadable (which is truly a shame).
When you have been able to sort out the assistance from Acorda, please let us know how that went. It is important that patients know what they have to do to get what they need.
Gave up on Ampyra? Invested in this and have some product left on the shelf? Then you migth be interested in a refund: e-mail ms2002live@gmail.com for information.