Does Emgality Help Migraine?

Does Emgality Help Migraine?

Emgality (galcanezumab) is a new Calcitonin Gene-Related Peptide (CBRP) for treating migraine.  The migraine process generates three neurochemicals, Neurokinan A, Substance P, and CGRP.  These neurochemicals are released by the ganglia of the trigeminal nerve and cerebral arteries.  They inflame the trigeminal nerve, the cerebral arteries, and the thalamus.  They also cause the cerebral arteries to dilate.  The thalamus is the “pain center” of the brain and only migraine inflames the thalamus like migraine does.  Triptans, if taken early in the migraine process, 20-40 minutes after headache onset, block the release of these inflammatory neurochemicals and are the best drugs currently for acute therapy for migraine.

Research involving cannulating the jugular vein and sampling chemicals in the blood as it leaves the brain has revealed that these neurochemicals are released by the migraine process.  After migraine starts there is an increase in the 3 inflammatory neuropeptides, and they go to the liver and then out of the body to the toilet.  Emgality blocks the activation of CGRP and is a new drug for migraine prevention.  None of the older preventive drugs for migraine enter into the migraine process and work like this.

The Migraine Timing Cycle

The Migraine Timing Cycle

The picture above is the Migraine Timing Cycle and stage 2 shows the release of CGRP.

Does Emgality Work For Migraine?  Yes, the FDA released Emgality for use in the United States in September 2018 and it has had grand success for migraine patients.  But perhaps more interestingly, it is the first drug recently developed specifically for migraine prevention. The only other one, Sansert, was used during the ’60s but now is off the market.  It is given as a subcutaneous needle injection either in the top of the thigh or near the umbilicus in the stomach.

Related questions. The first dose is 2 of the 120 mg injections, followed by one 120 mg injection once a month for migraine

What kind of injector is used for Emgality?  The first dose is 2 of the 120 mg injections, followed by one 120 mg injection once a month for migraine

Emgality subcutaneous injection

Emgality subcutaneous injection

Are there any special precautions with using Emgality?  Emgality should be stored in a refrigerator in its original carton to protect from light.  The Emgality needle should be left at room temperature 30 minutes before injection.  The thigh or abdomen should be cleaned with an alcohol sponge before injection.

Does Emgality interact with other drugs?  Most modern drugs are made from the dirt or plants in the world and then are processed by drug companies and used to treat a specific illness.  For instance, penicillin is a mold that accidentally dropped on an agar plate Fleming had put on his window ledge. It was found to kill bacteria and later manufactured and sold to treat bacterial illnesses.  Penicillin as 10 different drug contraindications.  This means that penicillin should not be used with those listed drugs.  However, Emgality can be used with any drug and has no drug to drug contraindication.

Emgality has no contraindications with other drugs.

Emgality has no contraindications with other drugs.

Emgality is made by DNA polymerization and then injected in the body.  CGRP drugs are made by DNA polymerization, a lab process of spinning out strands of DNA.  This is a completely novel method of drug production and safe regarding use with other existing drugs.

What are the side effects from taking Emgality?  Serious side effects are hypersensitivity reaction; common side effects are injection site reaction and muscle cramps or spasms.

Select Safety Information.  Emgality may cause allergic reactions, such as itching, rash, hives, and trouble breathing. Allergic reactions can happen days after using Emgality.  Users are instructed to their healthcare provider or get emergency medical help right away if they experience any of the following symptoms, which may be part of an allergic reaction:  swelling of face, mouth, tongue, or throat, trouble breathing

Serious side effects are very rare and the common side effects are not bad.  The injection site reaction is like the small bruise one gets following getting blood drawn in your arm for lab studies.

What are the benefits from using Emgality?  In two 6-month studies of adults who had 4-14 migraine days per month Emgality cut migraine days in half for about 60% of people vs. about 39% for placebo.

In a 3-month study of adults with 15+ headache days per month, 28% had their monthly migraine days cut in half or more with Emgality compared to 15% who took placebo.

A migraine-free month is possible.  This happened in 12% on average in one study and 16% in another vs. 6% who took placebo.  In a 3-month study, the number of adults with 15+ headache days per month who were migraine-free in an average month did not differ between Emgality and placebo.

Emgality was specifically developed for migraine.  Historically, many migraine preventive medicines were designed for other conditions. Emgality was specifically developed to bind to CGRP, a substance in the brain that may play a key role in migraine and block its binding to the receptor.

“The most exciting thing about these drugs is not the FDA-required endpoints,” says Alan Rapoport, MD, a clinical professor of neurology at UCLA’s David Geffen Medical School who has been a leader in headache research and treatment. The value of the CGRP class is its potential to significantly reduce migraines for a reasonable number of patients. He says about 30% of patients may see 75% reduction, and between 15% and 20% may see a 100% reduction.

These are astounding results for migraine therapy and much better than the results of any previously used migraine preventive drug.

 
Emgality rock on

Emgality rock on

 

What are the results of previous migraine preventive drugs?  The standard migraine preventive drugs are amitriptyline, topiramate, valproic acid, and the beta blockers-propanalol and atenolol. 

All of these drugs work indirectly on the migraine process, while Aimovig, blocking CGRP, acts directly in the migraine process.  These older preventive drugs could reduce migraines bout 30 % in a month and had a lot of side effects that resulted in poor compliance so that many patients just quit taking them.

Amitriptyline is an older antidepressant active at a dose of 100-125 mg and with reliable side effects of weight gain, dryness or mouth and constipation.  Neurologists use dose of 10-20 mg with reduced, but still active side effects.  However, it is the only migraine preventive drug, including the CGRP blockers, that helps with sleep and many migraine patients don’t sleep that well.

Topiramate is used at doses of 100-200 mg and also has predictable side effects of tingling lips and fingers, “cola tastes flat,” and trouble with cognition and word finding.  Despairingly patients called it “dopamax.”  Originally doses every 12 hours, long acting, once a day topiramate is available as Trokendi XR and Quedexy XR. It was originally used to treat epilepsy and then found to help with migraine.

Depakote ER or Valproic acid is another anticonvulsant drug later found to help migraine that has a complete contraindication for fertile women.  It may cause malformed or “teratogenic” defects in babies which is unfortunate because migraine prevalence peaks at age 42 where 25 % of women get migraine and they are still having menstrual cycles and can’t take Depakote.

The betablockers propanalol and atenolol prevent the vasodilation that occurs during migraine, but they can also slow the pulse.  They may cause a “tired syndrome” which makes them difficult to use although propranolol had the first FDA indication for a preventive migraine drug in 1974.

 
Previous oral migraine preventive drugs .

Previous oral migraine preventive drugs.

 

Special cardiovascular and cerebrovascular lack of risk.  Migraine, especially migraine with aura, has an increased risk of cardiovascular and cerebrovascular risk.  The main acute therapy drugs, the triptans, are contraindicated with cardiovascular and cerebrovascular disease because of a suspected increase of vasoconstriction with resultant heart attack or stroke.

However, an increasing number of studies show that vasodilation is not significant in migraine and that the new CGRP drugs are safe.  The CGRP drugs are new and there are cries from some headache experts that more research should be done to further certify that CGRP drugs don’t relate to cardiovascular or cerebrovascular disease.  Currently the FDA says that Emgality can be used in patients with cerebrovascular disease risk.

What about use of the new CGRP antibody drugs for pregnancy or lactation?  There is no current indication for the use of CGRP antibody drugs during pregnancy or while breastfeeding.  The FDA statement regarding CGRP antibody drugs is: 

Pregnancy-caution is advised during pregnancy.  No human data is available, no known risk of fetal harm based on animal data at 20 times recommended human dose.

Lactation–caution is advised for breast-feeding.  No human data available to assess risk of infant harm or effects on milk production.

 
Emgality should be taken during pregnancy or breastfeeding.

Emgality should be taken during pregnancy or breastfeeding.

 



Emgality !

Emgality !

Good luck with this.

Britt Talley Daniel MD

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