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4AP to be approved by FDA by the end of the year

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  • 4AP to be approved by FDA by the end of the year

    I talked to my SCI doctor and he told me that 4ap should be on the market by end of 08' beginning of 09'
    C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

  • #2
    4ap is approved already.

    Do you mean Famperdine by Acorda?
    And the truth shall set you free.

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    • #3
      no he said 4ap
      C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

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      • #4
        According to Dr Young, Famipridine (pharmaceutical grade of 4-ap) will possibly be available by the first quarter of 2009.

        /forum/showpost.php?p=906531&postcount=2
        Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

        T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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        • #5
          How will this help me? Is it worth talking to my doc. about "off label" use? I am diagnosed as T8 complete.

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          • #6
            Fampridine-SR

            Fampridine = 4-aminopyridine = 4-AP.

            The most common type of 4-aminopyridine available from compounding pharmacies is just 4-AP placed in a capsule with some filler material. This is sometimes called "immediate release". The recommended dose is no more than 10 mg four times a day. Because the drug is absorbed rapidly, it has more side effects and it is recommended that patients ramp up on the dose over a two week period. Start with 5 mg capsules, taking one a day. If this doesn't produce any side effects, take the 5 mg capsules twice a day (morning night). If no problems, go to three capsules a day and then four capsules a day. Then, substitute a 10 mg capsule for one of the 5 mg capsule, see what the effects and side-effects are. If no problem, substitute for more to a maximum of 10 mg capsules four times (every 6 hours) per day.

            Some compounding pharmacies provide a version of 4-AP called timed release or sustained release. However, to my knowledge, these have never been tested. They may not only delay absorption of the drug but reduce the total amount of the drug absorbed. Acorda Therapeutics is developing a formulation called Fampridine SR. This is designed to be taken twice a day (bid) and I believe that each capsule will contain 40 mg. Because the sustained release formulation slow down absorption, the side-effects are not as severe and higher doses can be taken. Fampridine SR is the version that was shown to be effective in improving walking speeds in patients with multiple sclerosis. Two phase 3 clinical trials showed that the drug improves walking speed.

            The US FDA is likely to complete approving the drug for multiple sclerosis in the coming months. I understand that the drug is scheduled to come onto the market in the first quarter of 2009. Acorda is now negotiating to make the drug available in Europe as well through a partner company. Although it is approved for MS, some doctors may be willing prescribe the drug for patients with SCI. The drug was tested in clinical trials of people with spinal cord injury and unfortunately did not show significant effects on spasticity in two phase 3 trials. Acorda Therapeutics is likely to initiate more clinical trials to determine whether the drug affects other outcome measures in spinal cord injury.

            Fampridine increases the excitability of axons so that demyelinated axons conduct more reliably and higher repetition rates. In addition, fampridine should also increased the amount of neurotransmitter (this is the chemical that communicates signals between one neuron and another) released per action potential (this is the signal carried by axons) that arrives at a synapse (this is the connection between one neuron and another). So, in theory, Fampridine should not have beneficial effects if the person does not have any axons crossing the injury site. However, if there are axons and they are demyelinated, fampridine improve the conduction. The improvements of function depend on the patient, how much demyelination they have, and how many axons they have. Improvements range from increased sensation and strength, to better coordination, and greater endurance.

            Some early studies suggest that only about a third of people with spinal cord injury would show beneficial effects. The drug seemed to reduce spasticity in some patients but this effect was not consistently seen in double-blind randomized and placebo-controlled studies. There were also early reports that it may reduce neuropathic pain this seemed to be balanced by reports of increased noxious pain (i.e. back pain) that might have been masked by the spinal cord injury. In any case, none of these turned out to be statistically significant in randomized trials, and therefore may not be real.

            The drug effects should be apparently shortly after the drug is started. The benefits should go away when the drug is stopped. Sensory improvements should be apparent early. However, motor function improvement may take days or weeks to show and may be improved by exercise and use. The drug effect is dose-dependent. In fact, 10 mg four times a day is just reaching the effective dose level. Higher doses of the immediate release formulation is not recommended because the risk of getting seizures increases with the dose. The sustained release version may allow higher blood levels of the drug with less side-effects.

            In MS, Fampridine-SR appears to be effective in improving walking across all MS subtypes. Response rates for the four major MS subtypes in the study were: relapsing-remitting: 37.2%; secondary-progressive: 45.9%; primary-progressive: 50.0%; and progressive-remitting: 40.0%. So, between 37-50% of people with MS show significant benefit. The response is not affected by immunomodulator drugs. The most recent trial indicates that Fampridine-SR significantly reduces spasticity in MS.
            http://phoenix.corporate-ir.net/phoe...087&highlight=

            While the drug may reach the market by the first quarter of 2009, many doctors may not have heard about the drug yet, particularly doctors who take care of patients with spinal cord injury. Accorda Therapeutics is working with neurologists who take care of people with multiple sclerosis. The drug should become available in Europe soon. Regarding availability of Asia, I am not sure when it will be available there.

            Please note, in the interest of full disclosure, while I am a member of the Board of Directors of Acorda Therapeutics, the above is what I understand and should not be taken as the official position of Acorda. People should go to the web site of http://ww.acorda.com for additional information. The company plans to file the NewDrug Application (NDA) in the First Quarter of 2009 (Source).

            Wise.

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            • #7
              Thank you for the info. Dr. Young.

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              • #8
                Have there been any attempts to deliver this drug via intrathecal pump?

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                • #9
                  Originally posted by Zero
                  Have there been any attempts to deliver this drug via intrathecal pump?
                  To my knowledge, no. Scientists have long used this drug directly on neurons but I don't know of anybody who has given this drug intrathecally. The drug readily crosses the blood brain barrier.

                  Wise.

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                  • #10
                    Originally posted by Wise Young View Post
                    Fampridine = 4-aminopyridine = 4-AP.
                    While the drug may reach the market by the first quarter of 2009, many doctors may not have heard about the drug yet, particularly doctors who take care of patients with spinal cord injury. Accorda Therapeutics is working with neurologists who take care of people with multiple sclerosis. The drug should become available in Europe soon. Regarding availability of Asia, I am not sure when it will be available there.
                    Wise.
                    Dr. Young,
                    If I'm not mistaken the qauick release compound loses its effectiveness if the mix is left sitting too long .. like if you mixed a batch now and pilled them... a few months from now the potency would be lessen in the mix that was taken at that later date... I thought I was told that early on in taking my 4AP....... is that true?

                    Would that mean Accorda pills might have less effectiveness if on the shelves for a little while post compounding?

                    Mine get compounded each month fresh from the local pharmacy

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                    • #11
                      Originally posted by RJC View Post
                      Would that mean Accorda pills might have less effectiveness if on the shelves for a little while post compounding?
                      I would think there would be an expiration date on the bottle just like all prescription medication. The quick release formula does lose its potency faster. With these independent pharmacies compounding the drug, you are rolling the dice when it comes to quality control.

                      You may want to take a look at this thread for more information on 4-AP and Fampridine-SR.
                      The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
                      --General George Patton

                      Complex problems need to be solved collectively.
                      ––Paul Nussbaum
                      usc87.blogspot.com

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                      • #12
                        Dr. Young,

                        Do you know if Acorda has established a manufacturer's suggested retail price, yet?

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                        • #13
                          Is Acorda working on anything else for SCI?
                          "Some people say that, the longer you go the better it gets the more you get used to it, I'm actually finding the opposite is true."

                          -Christopher Reeve on his Paralysis

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