Migraine Drug May Prevent Headaches in Hot Weather

By Pat Anson, PNN Editor

With a dangerous heat wave expected this week in the Midwest and Northeast, the National Weather Service has issued “heat alerts” from Iowa to Maine through Friday. Temperatures are expected to reach the mid to upper 90’s, although it will feel hotter due to high humidity in some areas.

Health experts are giving the usual precautions about heat safety, such as staying hydrated and avoiding strenuous outdoor activity, but migraine sufferers may just want to stay inside in a cool, dark place. While there are no clear links between hot weather and migraine, the American Migraine Foundation says that seasonal changes in weather can trigger a migraine attack.

There are currently no FDA-approved treatments for the prevention of weather-related migraines, but according to a preliminary study, one of the new migraine drugs that block proteins known as CGRPs (calcitonin gene-related peptides) may help prevent headaches in hot weather.

A team of researchers analyzed over 71,000 daily diary records of 660 patients with episodic migraine, comparing them with local weather data on the same days. They found that for every temperature increase of 10 degrees Fahrenheit, there was a 6% increased risk of a headache.

“What we found was that increases in temperature were a significant factor in migraine occurrence across all regions of the United States,” says lead author Vincent Martin, MD, director of the Headache and Facial Pain Center at the University of Cincinnati. “It’s pretty amazing because you think of all the varying weather patterns that occur across the entire country, that we’re able to find one that is so significant.”

When researchers took a closer look at migraine patients being treated with fremanezumab, which is sold under the brand name Ajovy, the association between hot weather and headaches completely disappeared.

Ajovy is an injectable migraine prevention drug made by Teva Pharmaceuticals, which funded the study. Teva also paid consulting fees to Martin, who is president of the National Headache Foundation.

“This study is the first to suggest that migraine specific therapies that block CGRP may treat weather associated headaches,” says co-author Fred Cohen, an assistant professor of medicine at Icahn School of Medicine in New York City.

Findings from the study were recently presented at the American Headache Society’s annual meeting in San Diego, California. If the findings are confirmed in future studies, Ajovy and other CGRP inhibitors have the potential to help migraineurs who suffer from weather-related triggers.

The medications are not cheap. The listed cost for Ajovy is $640 for one monthly dose, although out of pocket costs will vary depending on insurance.

Survey Finds Patients Wary of Trying CGRP Migraine Drugs

By Pat Anson, PNN Editor

Khloe Kardashian and Serena Williams have their work cut out for them. Despite their endorsement of a new type of migraine medication, many patients remain wary of the drugs and few have tried them, according to a large new survey.

The annual survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication, down from 29% in last year’s survey. And only 11 percent of patients said they were using a CGRP to treat migraine pain.

CGRP stands for calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved four injectable CGRP inhibitors (Aimovig, Ajovy, Emgality, Vyepti) to prevent migraine and two CGRP tablets for acute migraine (Ubrelvy, Nurtec). The latter two were recently endorsed by reality star Kardashian and tennis star Williams.   

Although Eli Lilly, Teva, Amgen, and other drug companies have aggressively marketed CGRP medications and even given the drugs away for free to get people to try them, sales growth has been slow. Only Aimovig and Emgality are used by at least 10 percent of migraine patients.

PERCENTAGE OF PATIENTS CURRENTLY USING CGRP INHIBITORS

SOURCE: HEALTH UNION 'MIGRAINE IN AMERICA 2020'

Most migraine patients continue to rely on older and cheaper medications such as triptans, anti-depressants, anti-convulsants, over-the-counter drugs, and Botox injections.

The Health Union survey helps explain why. While most patients are aware of CGRP inhibitors and nearly half (43%) had tried a preventive CGRP, most stopped taking them after trying just one brand. That’s not uncommon for migraine sufferers, who often have try multiple treatments before finding one that works.   

“Everybody’s experience with treatment is different. And the fact that there are multiple brands available is actually a really good thing. Because some of them just happen to work better for some people than others,” says Brian Green, Health Union’s vice-president of community business solutions.

CGRP’s do work for some patients. The Health Union survey found that 58% of patients currently using a preventive CGRP reported having less head pain. And nearly half said they didn’t react as strongly to migraine triggers such as loud noises and bright light.  

Those who had heard of preventive CGRP medications but had not tried them cited a number of reasons:

• 44% Doctor has not recommended it

• 27% Concerned about side effects

• 21% Concerned about long-term safety

• 19% Can’t afford them

• 14% Insurance won’t cover

CGRP medications are not cheap. Eight doses of Nurtec, the acute CGRP endorsed by Kardashian, can cost over $1,000 without insurance.

Nearly half the patients surveyed said they were still using triptans or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

New Migraine Prevention Drugs Making Inroads

By Pat Anson, PNN Editor

Over half the patients taking a new class of medication designed to prevent migraines say the benefits of treatment outweigh the drugs’ side effects, according to a new survey.

The drugs prevent migraines by blocking a protein — calcitonin gene-related peptides (CGRP) -- from binding to nerve receptors in the brain. Since 2018, the FDA has approved three injectable CGRP inhibitors for migraine prevention and recently approved the first oral tablet for migraine treatment.

Although the drugs are still relatively new, a recent survey of over 4,700 migraine patients by Health Union found that about a third (29%) are currently using a CGRP medication, while 12% had used one in the past.

Most said the drugs were effective at migraine prevention and worth the side effects, which include constipation, fatigue and weight gain. Only 9 percent said the drugs were not worth the side effects.

“CGRPs are in many ways a treatment revolution,” says Brian Green, vice-president of community development for Health Union. “There has not been a new class of medication specifically designed for treatment of migraine for decades. So this really is groundbreaking.” 

Green said patients with chronic severe migraine are more likely to be early adopters of CGRP therapy, as opposed to people who have episodic migraines and fewer attacks.   

Patients on CGRP therapy were more likely to say their migraine attacks increased over time and that they experience a wide array of symptoms, including head pain, brain fog, difficulty concentrating, fatigue, loss of words, memory loss and sensitivity to touch. 

“Their symptoms are so severe they want the first available new treatment,” Green told PNN. 

But the early adopters were also more impatient. Health Union’s survey found that patients who were not satisfied with a CGRP inhibitor wasted little time switching to a new brand. About 40% waited less than a month and 43% waited up to 3 months. Most of those who switched said the drugs did not work or stopped working after an initial period of efficacy. 

The three CGRP inhibitors currently on the market are Aimovig, Ajovy, and Emgality, which are taken by injection about once a month. The first oral CGRP for migraine treatment, Ubrelvy, was approved by the FDA last month and is expected to be available in the next few weeks.  

Most patients surveyed by Health Union said they would prefer taking a daily CGRP pill as opposed to a monthly injection.  

Constipation was the leading side effect reported by patients getting CGRP injections. Nearly a third said the drugs made them constipated, while others complained of reaction at the injection site (16%), fatigue (15%), weight gain (12%) and dry mouth (11%). 

About half the patients surveyed said they were still using a triptan or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

Regardless of the drugs used, only 12% of patients said their migraines were well controlled under their current treatment plan.  

FDA Approves Third Injectable Migraine Drug

By Pat Anson, PNN Editor

Migraine sufferers will soon have another treatment option. Eli Lilly has announced that the U.S. Food and Drug Administration has approved Emgality (galcanezumab), a monthly self-injected drug for the prevention of migraine in adults.

Emgality is the third injectable migraine drug the FDA has approved this year. In May, the agency gave approval to Amgen’s Aimovig (erenumab), the first migraine drug that uses fully human monoclonal antibodies to target receptors in the brain where migraines are thought to originate.  Last week, the FDA approved Teva’s Ajovy, a migraine prevention drug that can be injected monthly or quarterly.

Lilly said the efficacy and safety of Emgality was demonstrated in three Phase 3 clinical trials in patients with episodic or chronic migraine.

Emgality reduced the number of monthly migraine headache days by an average of 4.7 days in patients with episodic migraine and by 4.8 days in patients with chronic migraine.  

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, as well as sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”

Lilly said Emgality would be available “shortly” at a listed price of $575 for a single injection or $6,900 annually. That introductory price is identical to that of Aimovig and Ajovy, although various discounts or rebates could make the cost lower. Lilly said it would offer Emgality for up to 12 months free to patients with commercial insurance under its patient assistance program.   

“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible,” said Shaw.

Earlier this month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion of Emgality for the prevention of migraine in adults who have at least four migraine days per month. That positive opinion was referred for final action to the European Commission, which grants drug approval in the European Union.