LymeNet Flash: How to ask my doc if Fampridine-sr is not fda approved?

This is topic How to ask my doc if Fampridine-sr is not fda approved? in forum Medical Questions at LymeNet Flash.

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Posted by kissis (Member # 4165) on :

Im planning on seeing my doctor tomorrow and I am going to ask to be perscribed Fampridine-sr. I have lyme/M.S.
What mg should I ask to be started on? Also is this an easy script for him to write, also does it need to be compounded?
A quick reply would be much appreciated
Terri

Posted by bettyg (Member # 6147) on :

up for morning shift; another time, please ask this type of question in afternoon so others w/lyme/ms can help you out with their knowledge ok! thanks! good luck. [Big Grin]

Posted by DW213 (Member # 9590) on :

I took this med, prescribed a couple of years ago by my MS doc.

It does have to be compounded. I used a company that was familiar with the drug, and did not have a problem filling my scrip.

Unfortunately, it didn't do anything for me.

Posted by Aniek (Member # 5374) on :

It appears that it is still in the clinical trial phase, so not yet approved by the FDA. Here is a link to the manufacturer. http://www.acorda.com/pipeline_fampridine_ms1.asp

You can call and ask them for the most up to date status.

According to the website, they have just finished a Stage 3 clinical trial for Fampridine-sr for MS. A Stage 3 trial is the last stage of trials before the new drug application is submitted to the FDA for approval. It means it went through 2 prior stages of trials on humans.

There are some drugs where the FDA allows patients who do not qualify for clinical trials to use the drugs before approval. It usually is for very serious conditions when no other drug is available. That might be how you will be using this drug.

Also, here is the safety statement from their recent study results in people with MS

Safety Statement

In this study, adverse events were largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS, including an increased risk of seizures that appears to be dose related.

Following is a list of the most common adverse events reported in the study, with percentages representing the Fampridine-SR treatment group vs. the placebo group: falls (15.8 percent vs.15.3 percent), urinary tract infection (13.6 percent vs.13.9 percent), dizziness (8.3 percent vs. 5.6 percent), insomnia (8.3 percent vs. 4.2 percent), fatigue (6.1 percent vs. 2.8 percent), nausea (6.1 percent vs. 4.2 percent), upper respiratory tract infection (6.1 percent vs. 9.7 percent), asthenia (5.7 percent vs. 6.9 percent), back pain (5.7 percent vs. 0 percent), balance disorder (5.7 percent vs. 2.8 percent) and headache (5.7 percent vs. 5.6 percent).

Two serious adverse events that were judged potentially related to treatment and led to discontinuation were anxiety in one subject and a seizure in another subject that was observed during an occurrence of sepsis associated with a urinary tract infection.

No deaths occurred during the study.

One death was reported for a subject five weeks after the last on-drug study visit. This death occurred outside of the protocol time window for reporting adverse reactions and the cause of death is not known at this time.