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New Migraine Medication Ready to Apply to the FDA for Release

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Sooner than expected, the migraine medication currently known as galcanezumab finished its phase III trials, and is preparing to apply to the FDA in the United States later this year.

Galcanezumab is a medication from Eli Lilly, in the new class (and much anticipated) of migraine medications known as CGRP inhibitors. There are a number of these medications approaching the finish line in their trials.

So how did galcanezumab perform in these trials? Very well, and as expected from previous trials.

The charts below show how many “migraine days” were eliminated by using 120mg of galcanezumab as opposed to a placebo. For episodic migraine, as tested over 6 months:Galcanezumab for episodic migraine

For chronic migraine, testing over 3 months, the results were equally positive, cutting almost 5 migraine days per month:Galcanezumab for chronic migraine

This means that the new drug could give patients over 55 more migraine-free days per year.

With these positive results, Eli Lilly will be submitting what is called a Biologics License Application to the FDA, which is basically a request to be allowed to sell their product throughout the country. After that, they will begin applying in other countries worldwide. This will start in the last half of this year.

Official press release from Eli Lilly: Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine

Candesartan for Migraine

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Recently a HeadWay subscriber mentioned a treatment that has been working well for her, and I realized that I haven’t mentioned it before. So here is a brief description of candesartan and its use in migraine treatment.

Candesartan is sold under the brand names Atacand, Amias, Blopress, and Ratacand, although it’s also available as a generic drug. It’s classified as an angiotensin II receptor blocker (ARB). ARBs are often used to treat hypertension, and candesartan is no exception. But antihypertensive drugs are also used as migraine preventatives.

In 2013, a study compared candesartan with a more common migraine preventative, propranolol. The study concluded that 16mg daily of candesartan was comparable to 160mg of propranolol – both led to fewer days with migraine symptoms. (see A comparative study of candesartan versus propranolol for migraine prophylaxis)

Sometimes we make the mistake of thinking that just because we’ve tried a certain kind of drug, we shouldn’t bother trying similar drugs. But the truth is that every drug – even sometimes different versions of the same drug, can have a different effect on an individual. That’s why candesartan can help a patient when propranolol might not, or vice versa.

As always, talk to your doctor before trying any medication. You may not need 16mg – a lower dose may be helpful. Candesartan is NOT for use by anyone who may be pregnant.

Another bit of good news is that candesartan may be a better option for patients concerned about weight gain.

If you’re interested in trying a new preventative medication, talk to your doctor about candesartan. It’s now an often recommended option.

Beta Blockers: Migraine

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This information on beta blockers: migraine is a step back to some of the basics regarding migraine treatment. Just what are beta blockers, and why are they used for migraine?

Beta blockers, also called beta-adrenergic blocking agents, are medications used for both migraine and blood pressure issues. They work by blocking certain neurotransmitters (norephinephrine and epinephrine) so that they won’t bind to certain beta receptors on nerves.

In this way the drugs reduce your heart rate and reduce blood pressure by dilating blood vessels. Different beta blockers have a slightly different effect on your cardiovascular system.

Beta blockers for migraine are given as preventatives. Some of the most effective beta blockers for migraine are metoprolol, propranolol, and timolol.
beta-blockers-migraineIn 1966, a patient using beta blockers for a heart condition experienced a dramatic improvement in migraine symptoms. In the 1970s, beta blockers started to be tested and used for migraine on a regular basis.

It’s easy to jump to the conclusion that the effect of beta blockers on the cardiovascular system is the direct reason why they prevent migraine. After all, we’re very familiar with that pounding, pulsing pain – why wouldn’t relaxing of the blood vessels help?

But of course it’s not that simple. Believe it or not, that pounding is not directly related to your heart beat. So today, migraine experts are not certain about just why some beta blockers help some patients.

Before taking beta blockers for migraine, your doctor will need to know your medical history. People with certain heart conditions, lung conditions, or those taking certain other medications, may not be able to take beta blockers. There are also other migraine treatments that you may want to try first.

Today, there are various beta blockers you can take for migraine, and there are various ways you can take them. If one doesn’t work, another might.

One of the most interesting recent discoveries is that beta blocker eye drops may even be effective abortive migraine-fighters! See $5 Eye Drops to Stop Migraine Attacks?

Common side effects of beta blockers include fatigue, weight gain, trouble sleeping, nausea, sexual dysfunction, and shortness of breath. Some of these will depend on the dosage and the type of beta blocker. Your doctor can help you choose what to try first.

For more information, see:

New Study Questions Preventative Migraine Drugs for Kids

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Just how effective are migraine drugs for kids? A new study is raising some interesting questions about whether or not we should be relying on them.

The study, published in the New England Journal of Medicine, tested topiramate and amitriptyline, both common preventatives. 328 children and adolescents were involved in the trial, which randomized, double-blind and placebo-controlled. A 24 week trial of the medications took place, and a 28 day window of results was compared – once before the medication, and once at the end of the 24 weeks.

The goal was to see a reduction of symptoms of at least 50%. So – how did the medications do?
Amitriptyline trial
As you can see, 52% of those on amitriptyline had a 50% or more reduction in symptoms. Pretty good. Let’s check out topiramate:
Topiramate trial
Even better – 54%. But here’s the problem. Being an well-designed trial, some of the patients were given a placebo – they didn’t take any medicine at all. How did these patients do?
Placebo success
That’s right, the ones who thought they might be taking medicine, but weren’t – they did the best of all.

To further complicate matters, some of the patients experienced side effects from the topiramate and amitriptyline – in some cases, quite serious ones.

Now before we completely write off preventative drugs for children and youth, there are some things to consider. First, this trial only tested one formulation and dose each of two drugs. There are a lot more options out there.

Second, it could very well be that some of these children were greatly helped by the medication who would not have been helped as much by the placebo. Remember, many patients saw a significant reduction in symptoms, and in some cases the medication may have helped with that.

But although this should not be a reason to write off preventative medications for children with migraine, it should suggest that you’ll probably want to try other treatments first – especially non-drug options. Diet, exercise, and certain complimentary treatments are excellent options for children. Take for example biofeedback, physiotherapy and certain supplements.

For more information, see the study abstract here: Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine

Also see: Dealing with child migraines? and Pediatric Migraine Medication

CGRP Inhibitor Race

Approaching the Finish line: CGRP Inhibitors

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For the last few years we’ve been watching the race to get CGRP inhibitors on the market for migraine prevention. Well, you could be seeing those drugs approved as early as next year. What’s the latest?

First, if you need to review exactly what CGRP inhibitors are, check out The Secret of CGRP.

CGRP Inhibitor RaceLeading the pack at the moment is erenumab, also known as AMG 334. In September, the report said that 70mg of erenumab, delivered by injection, had almost 3 fewer days of migraine attacks per month. These are episodic migraine sufferers who originally had between 4 and 14 migraine days per month. That means that if you could have about 30% fewer attacks, and side effects seem to be few.

Erenumab now moves into the second part of the trial, testing different dosages over 24 weeks.

Also in Phase III trials is galcanezumab, also known as LY2951742. Galcanezumab also had statistically significant results in previous trials, with a once-a-month injection, and participants are currently being recruited for new trials – those with chronic and episodic migraine, and those with chronic and episodic cluster headache – for more information visit ClinicalTrials.gov.

A little further behind, but possibly the one to watch in 2018, is TEV-48125. A once-monthly injection at various doses was tried, and as early as 3 days into the treatment patients had positive results. Studies continue for both chronic and episodic migraine.

Finally, let’s not leave out ALD403. ALD403 is well on its way for treatment of episodic and chronic migraine, though the episodic migraine trials are further along.

Many patients taking ALD403 in trials actually experienced a complete remission of migraine, and others a significant decrease. Trials continue.

These are just tidbits of information about the trials, and they really can’t be compared at this point, even if we did have all trial data. The point is that these still look like solid options to prevent episodic and chronic migraine, and even cluster. Some if not all of these should roll out over the next 2-3 years, and by that time we’ll know them better.

For more information, see:

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The articles on Headache and Migraine News are © 2004-2026 J. Cottrill.
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