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Ajovy for Migraine – and Cluster? Another New Drug

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Ajovy (fremanezumab-vfrm) (formerly called TEV-48125), a new anti-CGRP drug for migraine, was approved in the USA by the FDA last month.

Like Aimovig, Ajovy is taken by injection. It can be taken monthly, but unlike Aimovig it was also approved to be taken quarterly. A study that we talked about back in January showed that Ajovy was only slightly more effective when taken monthly. For many people, an injection every three months sounds a lot better than every month!

AJOVYYou can read more about the history of this drug, along with more useful information, in the press release from Teva: Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults

So what about cluster headache? Though not yet approved for cluster, there are some signs that Ajovy and/or future anti-CGRP drugs may help a lot of cluster patients. If you’re interested in the technical details about the link between CGRP and cluster, check out For Your Patients-Cluster Headache: CGRP Implicated in Cluster Headache Attacks at Neurology Today.

Teva decided to scrap its trial of Ajovy for chronic cluster, when it didn’t look like the results would be as good as hoped. They do have high hopes for treatment of episodic cluster.

But even if Ajovy doesn’t turn out to be the best option for cluster patients, it does look very hopeful that one of the other CGRP related drugs may help bring significant relief.

Meanwhile, Ajovy is full-steam-ahead for migraine patients. For more information, visit the official Ajovy website here.

Rugby

Yes, there is a Blood Test for Concussion (but how will it be used?)

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This February in the USA, the FDA approved a blood test for concussion (also known as mild traumatic brain injury). This is a remarkable step forward, but its usefulness may be in the future, not in the present.

Normally, patients who suspect they have a concussion will be evaluated by a doctor, and then they may be given a CT or MRI. If the scans show intracranial lesions (which most of the time they don’t), it will help the doctor know how to treat you.

The new blood test is officially called the Banyan Brain Trauma Indicator. Used within 12 hours of the injury, it measures proteins in the blood, and can predict how likely it is that a patient will have intracranial lesions.

The test is remarkably accurate – almost 99% accurate.

RugbyBut just how this test will be used in the short term isn’t certain. Will it actually help patients avoid a scan? Well, first patients would have to chose the slower choice – waiting several hours for blood test results instead of the much quicker scan. If it seems that the patient is likely to have intracranial lesions, will the doctor call for a scan anyway? And if they’re feeling sick and the test comes back negative, will a CT scan be called for in case they’re the 1% that the test doesn’t work for?

Of course everyone wants to avoid scans, lower health care costs, and have better diagnoses. But it may take some time before this test is actually useful in the real world.

There are a couple things that would be helpful, at first glance. First, this test is approved for adults, not children. But the company is working on a trial for children, so that’s coming.

Second, it would be interesting to see results from this test or similar tests correlated with symptoms. In other words, could a blood test predict how likely I am to have serious symptoms, or long term symptoms, from a concussion?

The problem is that most CT scans come back negative – and so presumably most blood tests would be negative too. But if levels could predict my risk for symptoms, the test could be a lot more useful.

Here are some more resources so you can dig deeper into this new test:

Device Approved for Migraine in the USA: gammaCore

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Two weeks ago, the gammaCore device was finally approved for migraine treatment by the FDA. You can read the press release from the company here: gammaCore® Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients
gammaCore
The device is not new – it’s been used for migraine and cluster headache for quite some time. It’s a non-invasive vagus nerve stimulator, which means no implanted devices.

Kerrie Smyres over at The Daily Headache has put up some excellent information about the device, so I’ll link to our previous information here, and her newer info, which also discusses cost and insurance (brace yourself – this treatment is not cheap right now!). But first, here’s a video from the makers of gammaCore [sorry, video no longer available].

Serotonin Syndrome: Are Triptan Users Really at Risk?

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Back in 2006, the FDA in the USA issued a warning about using triptan medications along with certain antidepressants because of the risk of serotonin syndrome. But how high is the risk? New studies suggest that the risk is extremely low, and that thousands have been mixing the medications with no problem.

What is the concern?

Serotonin syndrome can be serious, even fatal. It is caused by excessive accumulation of serotonin, and important neurotransmitter, in the body. Some medications and herbs have been associated with the problem, the idea being that they work to cause runaway levels.

This includes triptans, commonly used for migraine, and certain antidepressants – selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs).

There has been some suggestion that triptans alone could lead, in rare cases, to serotonin syndrome.

This is an important question, because many migraine patients also suffer from depression. And to be clear, for most migraine doctors, this was a “use with caution” warning, not a prohibition.

Re-evaluating the Research

Just because there is a “risk” doesn’t mean you should avoid something. Just because you have a “risk” of falling down the stairs, doesn’t mean you avoid stairs.

So here’s the question – just how high is the risk?

Researchers in Houston in the USA went back to check out the original research that the FDA had in 2006. They found that the evidence should not have been considered sufficient for the FDA warning. The evidence was “Class IV” – the lowest possible level. (See the abstract here: The FDA alert on serotonin syndrome)

Another study, presented at the 59th Annual Scientific Meeting of the American Headache Society, provided even more reason to question the warning. Over 14 years, about 19,000 patients who used both triptans and SSRI or SNRI antidepressants were evaluated – and between 4 and 7 patients developed serotonin syndrome. That’s about a 0.03% risk.

Of those patients, how serious was their condition, and do we even know for sure that it was caused by the medications? Serotonin syndrome, although it can be serious, usually is not fatal.

Of those patients, only two cases were related to triptan medications. And in one of the cases, the symptoms started before the patient took the triptan!

In the end, one of the researchers said simply,“Our data do not suggest a clinically meaningful risk of serotonin syndrome in patients coprescribed triptans with SSRI/SSNI antidepressants.”

Read more about this report: Triptans, Antidepressants, and Serotonin Syndrome: How Real Is the Risk?

Risk?

From these studies, it seems that with regular use of triptans and antidepressants, the risk is almost nil. However, because of the seriousness of serotonin syndrome, patients should be aware and should report new symptoms to their doctor. It is also important to remember that there is concern about “street drugs”, taking more than is prescribed, and certain supplements such as St. John’s wort and ginseng. Your doctor needs to be aware of what other drugs and supplements you’re taking.

For more information on the drugs that have caused concern, see Serotonin Syndrome: Symptoms and causes.

via: Triptans (like Imitrex) mix well with antidepressants

Zecuity Patch Sales Halted Over Burn Concerns (important information)

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Zecuity, the skin patch for migraine, has had a bad month.

On the 2nd of June (this month), the FDA announced that they are investigating the risk of burns from the patch:

The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.
FDA Drug Safety Communication

Zecuity packageOn the 10th, Zecuity manufacturer Teva Pharmaceuticals decided to temporarily stop sales and marketing:

Teva has been working closely with the FDA to examine reported adverse skin reactions associated with ZECUITY usage. At Teva, we are deeply committed to the safety and well-being of people who use our products. As such, we have decided to engage in a voluntary suspension of the sale, marketing, and distribution of ZECUITY while we continue our investigations into the root cause of these adverse skin reactions. In keeping with this market suspension, we have initiated a pharmacy-level recall of the product.
Letter from Teva

Patients are advised to stop using the Zecuity patch right away.

The symptoms some patients have reported include itching, burning, and other pain. Some of the skin reactions were not resolved after several months.

It’s not clear exactly what is causing these reactions. This is, of course, a well-tested product. It’s hard to speculate whether the product could actually return to the market as-is with further warnings/instructions, or if it will have to go back for further testing.

Zecuity is a method to take sumatriptan. If any medication can be taken in many ways, it’s sumatriptan. However, as we all know, there are those out there who have probably been helped by Zecuity who haven’t been helped by other treatments. (More on this product)

Another issue is that this technology holds great promise for other migraine treatments and beyond. It would be a shame if there was another major setback, although hopefully this will be an opportunity to further improve skin patch products.

Important to know:

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