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FDA approval...new migraine preventive drug... (Read 645 times)
jon019
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FDA approval...new migraine preventive drug...
Sep 14th, 2018 at 6:56pm
 
Yeah...I know...the "M" word...but clusterheads have had to tag along behind treatments for that FOREVER anyway....

Best

Jon

PS I tried to post in a more friendly form with active links...unable...try FDA.gov (Ajovy)

                       
     The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA
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     Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy is the second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. Aimovig (erenumab-aooe), the first in this class, was approved on May 17, 2018.

Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Migraine attacks can cause significant pain or hours to days and can be so severe that the pain is disabling. Warning symptoms known as aura may occur before or with the headache. These can include flashes of light, blind spots, or tingling on one side of your face or in your arm or leg.

Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity reactions, including rash, pruritis (itching), drug hypersensitivity, and urticaria (hives) were reported with Ajovy in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. The most common adverse reactions were injection site reactions and infections.

For more information, please visit: Ajovy (fremanezumab-vfrm) .

                 
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Mike NZ
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Re: FDA approval...new migraine preventive drug...
Reply #1 - Sep 14th, 2018 at 7:51pm
 
There have been multiple CGRP blocking migraine preventives which have been released which seem to help some people (great that it does) but they cost several thousand dollars.

There have been trials using them with CH, but at least one of the trials has been discontinued. I posted about it here a few months ago.
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General_Cluster
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Re: FDA approval...new migraine preventive drug...
Reply #2 - Sep 30th, 2018 at 2:18am
 
Aimovig targets the trigeminal headache pathway. Cluster headache is a trigeminal syndrome, migraine is not classically in that pathway but it may be involved. Aimovig works to prevent clusters, in my case.
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RickJim
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Re: FDA approval...new migraine preventive drug...
Reply #3 - Apr 30th, 2019 at 7:56pm
 
General_Cluster ... did Aimovig worked right away after the first injection? Or did you have to use it several months in a row to see results?

I am in Vitamin D3 treatment but it works only partially.  I still get my regular cycle at the expected month of the year, but the headaches are less intense. My neurologist suggested to start Aimovig since it seems that my cycle might be starting.

What is your experience?

Rick
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Batch
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Re: FDA approval...new migraine preventive drug...
Reply #4 - May 3rd, 2019 at 12:16pm
 
Hey RickJim,

Have you seen your PCP/GP for the lab test of your serum 25(OH)D?  Off hand, I'd say it's too low if the CH beast starts prowling around at the usual cycle time... 

I'd take a 50,000 IU vitamin D3 loading dose for a few days then bump the vitamin D3 maintenance dose by an additional 5,000 IU/day to 15,000 IU/day.  If the CH beat still jumps ugly during its usual cycle time, I would take the 50,000 IU/day vitamin D3 loading dose for a week then drop back to a new vitamin D3 maintenance dose of 20,000 IU/day.

CH pathology occurs within the brain and more specifically, within neurons in the trigeminal ganglia where CGRP is expressed during a CH.  Aimovig molecules are too large at 150,000 Da to pass through the blood brain barrier (BBB) windows at 400 Da.  Accordingly, Aimovig cannot reach neurons within the trigeminal ganglia where CH pathology occurs.  At best, it lowers serum level concentrations of CGRP.

Vitamin D3 down-regulates the expression of CGRP within neurons in our trigeminal ganglia.  As it has a molecular mass of 385 Da vitamin D3 and its first metabolite, 25(OH)D has a molecular mass of 400 Da, both pass through the BBB and enter neurons within our trigeminal ganglia to down-regulate CGRP expression.

Take care and please keep us posted.

V/R, Batch
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