Transitioning from 4-AP compound to Ampyra

[Random]

Wise, do you know if doctors can prescribe more than the 20 mg of Ampyra per day or if the manufacturers are ever considering marketing a higher dose?

I used to take 60 mg of 4-AP per day (four doses of 15 mg) and I really feel the drop of function on Ampyra. The 4-AP never did anything really miraculous for me, but it makes the difference between my being able to do two finger keystrokes like ctrl-u or move my little pointer nub effectively. I don't know if you officially can answer this question, but is there any real danger to just taking more Ampyra? My very first dose oddly gave me the tingles in my face, but after that I felt nothing.

It would be great to take the amount that I need and have it covered by insurance.

[peegy p]

I have the same concerns. The Ampyra is not as effective as the 4-AP. I have experienced a decline in strength and sensation. I believe it is the change in dosage from 40 mgs/day of 4-AP to 20 mgs of Ampyra. My insurance no longer covers either drug. The Ampyra is $70/month out of pocket for 20 mgs; the 4-AP is $140/month for 40 mgs. I also feel insulted each month when Accredo Pharmacy calls to read the same scripted questions. Their computers keep track of when are perscriptions are due and having to pay for over-night delivery when they drop it at the door adds to the excessive costs. I seriously doubt that they will allow for increased dosages since they are still conducting their follow-up studies.

I hope Dr Young chimes in with additional information.

[SCI-Nurse]

I will PM Dr. Wise and let him know to take a look.
CKF

[retto76]

I would be interested to know this as well. I am on Ampyra and had phenomenal results for almost 2 months. I was doing more in PT, I was able to take a few independent steps while in the parallel bars, had actual temperature sensation in my feet, got back some texture sensation in my fingers, etc. Now the effects have dropped back a lot. I went off the drug for several days, thinking that it wasn't working, but then I noticed my weak foot got much, much weaker - to the point that I could not lift it at all but could only do a shuffling drag to try to walk with my walker. I also lost much more sensation during those few days. After restarting, I'm back to the 'normal' that I was at before quitting. But after experiencing the phenomenal results of the first 6-8 weeks, I would absolutely love to do that again. I've wondered if taking more of the drug would help, but I'm a little nervous of the possible seizures that can experienced if there's an overdose.

Also - Peegy - isn't there a program that the drug company has that makes sure nobody pays more than $40 out of pocket per month for Ampyra? Maybe you could check into it. My 3-month co-pay is $125 for a brand-name drug, but this program kicks in a whopping $5 so that it averages to the $40/mo that they deem is a 'fair' price.

[peegy p]

Retto 76

I haven't heard of a discounted price. My perscription drug program is managed by Medco and they will not cover either drug. I had Express Scripts up until July 2010 and they covered $104 of the $140 for 4-AP, but then the powers that be decided to change the drug companies. Who would I contact for a reduction in cost since my drug plan will not pay for either drug?

[retto76]

Here is a link on Ampyra's (Acorda's) webpage:
http://ampyra.com/newly_prescribed/financial/

Here is a paragraph for people with insurance and high co-pays:

AMPYRA Patient Support Services and Co-Pay Program

If you are prescribed AMPYRA, AMPYRA Patient Support Services will confirm your insurance and your eligibility for the co-pay program. This program is for people with private insurance, where allowed by law. If you are eligible, you may not pay more than $40 per month for AMPYRA.

There is also a paragraph for people who don't have insurance coverage for Ampyra, which may also pertain to you.

I hope this helps!

I have a Medco plan for rx's too. It wouldn't cover 4-AP (because it's "experimental"), but it does cover the incredibly expensive Ampyra version!! I have to go thru their specialty pharmacy - Acredo.

[SCI-Nurse]

Just as a FYI for everyone - many, if not all of the pharmaceutical companies have similar programs for their drugs. It is certainly worth looking into on their websites - even if it only save you a few $$ - it could make the difference between being able to continue on it and having to stop it.

CKF

[Wise Young]

Originally Posted by Random

Wise, do you know if doctors can prescribe more than the 20 mg of Ampyra per day or if the manufacturers are ever considering marketing a higher dose?

I used to take 60 mg of 4-AP per day (four doses of 15 mg) and I really feel the drop of function on Ampyra. The 4-AP never did anything really miraculous for me, but it makes the difference between my being able to do two finger keystrokes like ctrl-u or move my little pointer nub effectively. I don't know if you officially can answer this question, but is there any real danger to just taking more Ampyra? My very first dose oddly gave me the tingles in my face, but after that I felt nothing.

It would be great to take the amount that I need and have it covered by insurance.

Randy,

As you know, Ampyra has been approved for multiple sclerosis (MS) but not for spinal cord injury (SCI). A doctor can prescribe a drug for anything but a company (or its representatives) cannot claim that a drug is effective for any condition other than the approved indications. I am a member of the Board of Directors of Acorda Therapeutics and therefore cannot discuss the drug or its efficacy for non-approved indications. I can speak generally about 4-aminopyridine (4-AP) for MS.

The mechanism of 4-AP is relatively well understood. 4-AP blocks the fast voltage sensitive potassium channel. This channel opens in axons and allows outward movement of potassium ions, causing a hyperpolarization of the membrane potentials to terminate the depolarization associated with opening of sodium channels during an action potential. What it does is to prolong the action potential in axons. A longer duration action potential increases the ability of the action potential to conduct in partly demyelinated axons. In addition, when the action potential arrives at the pre-synaptic terminal, it results in longer depolarization and hence more calcium entry into the terminal to release more neurotransmitters. In other words, it increases the signal (action potential) that is conducted in demyelinated axons and the amount of neurotransmitter released by the synapse.

Clinical trials conducted by Acorda Therapeutics have shown that 4-AP improves walking in people with MS. This was one of the outcome measures that Acorda Therapeutics chose to measure. There has been some criticism of this measure because, on average, people walk several seconds faster on a timed 10-meter walk. On the other hand, this was a very reproducible and statistically highly significant effects of Ampyra in people with MS. The drug has other effects on people but it is very difficult to carry out clinical trials to assess function in MS because the deficits range widely from patient to patient.

Ampyra is a long-acting form of immediate release formulation of 4-AP. The compounded pharmacy version of 4-AP, which many people took before Ampyra was approved, is absorbed rapidly and reaches a peak in the blood shortly after being taken. It then is cleared within 6 hours. This was why people took 4-AP four times a day. Ampyra is released much more slowly, is taken only twice a day, and maintains more stable blood 4-AP levels. Because the peak blood levels of 4-AP are lower with Ampyra, it should have less side-effects. 4-AP increases the likelihood of seizures and people with MS tend to be more sensitive to having seizures, the dose recommended for people with MS is 20 mg per day, i.e. 10 mg twice a day. As you know, this is half of daily dose that many people were taking for the immediate-release 4-AP for SCI. On the other hand, the dose of 10 mg is the same amount of drug but just repeated twice rather than four times.

I hope that this is helpful.

Wise.

[MSWIFE1]

Wise - any reason that you can mention on here that someone would loose some of what they have regained since initially starting Ampyra. David like Retto (above) started Ampyra with remarkable results but it has diminshed considerably. Just wondering why????

[Brad]

I was in two of the fampridine trials for SCI taking 20mg x2 for nearly a year five or six years ago. Not wanting to wait for the FDA approval process I stared compounded sustained release 4ap taking 10mg x 4 until Ampyra was available. I weened off 4ap over several weeks as the Doctors and pharmacists all strongly suggested reaching 0 before starting Ampyra. The last week AT 10mg SUCKED! If anybody doubts the benefits of this drug all they had to do is attempt range of motion exercise. My morning girl struggled to bend my knees. The Ampyra kicked in immediately but doesn't seem to work as well at this stage of the game. My Doctor's office just informed me the FDA will not approve a higher dosage. I'm now considering the option of returning to compounded 4ap or mixing the two for 40mg. Has anybody tried mixing?

Brad Stoddard