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Laquinimod
Laquinimod is an oral treatment for multiple sclerosis. It's taken once a day. This would be a welcome treatment for many MSers who don't like taking injections. Or for those who just can't tolerate the available immunomodulating drugs or the medications didn't work very well.
Laquinimod studies
There were several studies done to see if laquinimod would slow down the progression of MS. A study called Allegro was done in 2007 and 2008. Another, a Phase 111 study called Bravo was begun in 2008 and was still going on as of June of this year, 2009. It is expected to be completed around November of 2011.
The Bravo study is being done to see if the oral medicine will work along with Avonex, the once a week injection. Because of the results of the previous studies, the FDA put the oral medication on what's called a Fast Track designation.
Fast Track is for drugs intended for conditions which are thought to be serious or life-threatening. It is used when the FDA feels that the drug meets medical needs that are not currently being met by other medications. This could make this oral treatment available as soon as 2011.
A failed medication – linomide - was developed by Active Biotech. Then they licensed laquinimod to Teva Pharmaceutical Industries Ltd. Teva also did a study with the medication as a treatment for Crohn's disease.
This medication is for you if you have relapsing-remitting multiple sclerosis. Those participating in the study, could be a man or a woman between the ages of 18 to 55. Below are a few other rules in order to be included in the study. As well as a list of things that would keep you from participating.
Who can take it?
To be included the following needed to be true:
- Willing and able to give written informed consent
- Confirmed MS diagnosis as defined by the McDonald criteria
- R-R MS disease course
- Subjects must be in a stable neurological condition and free of corticosteroid treatment (steroids)
- Women of child-bearing potential must practice a reliable method of birth control
- Must understand the requirements of the study and agree to comply with the study protocol
You were excluded if any of the following applied to you:
- Subjects who suffer from any form of progressive MS
- Any condition which the investigator feels may interfere with participation in the study
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
- Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
- Previous treatment with immunomodulators within two months prior to screening
- Pregnant or breastfeeding
Found at Clinical Trials.gov (According to this page - opens in a new window - they are no longer recruiting
Any side effects?
According to the study, this oral medication seems to be very well tolerated. Some participants in the study did experience increased liver enzymes. This is only a temporary condition, however.
Well, we'll just have to wait and see. I'm sure for many Msers who are taking injections, an oral alternative is welcome news. Especially if you don't like needles. As long as you have one of the relapsing forms of MS, you should be good to go.
Go from Laquinimod back to Multiple Sclerosis Medicines
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