Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” said Billy Dunn, M.D., acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research . “Ubrevy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. Dunn called the drug a “novel treatment for patients suffering from migraine.”

An estimated 37 million people in the U.S. are affected by migraine, the FDA says.

Migraine headache pain is often described as an intense throbbing or pulsating pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one third of individuals who suffer from migraine also experience aura shortly before the migraine. An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision. Migraines can often be triggered by various factors including stress, hormone changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10% of people worldwide.

The effectiveness of Ubrelvy for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. In these studies, 1,439 adult patients with a history of migraine, with and without aura, received the approved doses of Ubrelvy to treat an ongoing migraine. In both studies, the percentages of patients achieving pain freedom two hours after treatment (defined as a reduction in headache severity from moderate or severe pain to no pain) and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped two hours after treatment were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo. Patients were allowed to take their usual acute treatment of migraine at least two hours after taking Ubrelvy. 23% of patients were taking a preventive medication for migraine.

The most common side effects that patients in the clinical trials reported were nausea, tiredness and dry mouth. Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.

Reyvow is not indicated for the preventive treatment of migraine.

“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans,” said Nick Kozauer, M.D., acting deputy director of the Division of Neurology Products in the Food and Drug Administration’s Center for Drug Evaluation and Research. “We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine.”

Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura shortly before the migraine. An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision. Migraines can often be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet. Migraine is three times more common in women than in men and affects more than 10% of people worldwide.

The drug’s effectiveness was demonstrated in randomized trials.

The effectiveness of Reyvow for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. A total of 3,177 adult patients with a history of migraine with and without aura treated a migraine attack with Reyvow in these studies. In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo. Although patients were allowed to take a rescue medication two hours after taking Reyvow, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration. Twenty-two percent of patients were taking a preventive medication for migraine.

There is a risk of driving impairment while taking Reyvow. The FDA advised patients not to drive or operate machinery for at least eight hours after taking Reyvow, even if they feel well enough to do so. Patients who cannot follow this advice are advised not to take Reyvow. The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.

The most common side effects that patients in the clinical trials reported were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.

The FDA granted the approval of Reyvow to Eli Lilly and Company.

These headaches and the associated symptoms are considered among the top 10 most disabling illnesses in the world with an unknown cause. Providing relief require a breadth and depth of treatment that must include non-pharmacological remedies for both treatment and prevention.

A wide range of physiological and emotional triggers for migraine have been identified.

Despite the recounting of anecdotal reports and scientific research, the cause of migraines remains a mystery. Neuroscience suggests that a migraine results from abnormal activity in the brain, affecting the way nerves, chemicals and blood vessels communicate. A wide range of physiological and emotional triggers have been identified, including stress, trauma, depression, anxiety, agitation and enthusiasm.

There are a number of lifestyle activities that can mitigate migraine triggers and provide relief in both duration and intensity of the migraine episode. Trying them alone or in combination with medical management, may help improve general well-being.

Before you become a sufferer or in an effort to prevent the next migraine, consider integrating these suggestions into your lifestyle.

• See a physician for an accurate diagnosis. This essential decision will allow all other neurological conditions to be ruled out. The physician can establish a definitive diagnosis based the symptoms of migraine headache. The diagnosis is necessary for evaluating medical and pharmacological treatments.
• Maintain a detailed headache diary. Use a diary to identify and examine triggers, track time between migraine attacks as well as the duration of each migraine. Tracking sleep schedule in the headache diary daily can be helpful. This can provide accurate information about changes in sleep patterns and provide additional data to support a comprehensive treatment plan.
• Manage your diet. Dietary management that includes consistent meal times, adequate hydration and the avoidance of meal skipping can contribute to a reduction in migraine episodes, duration and intensity of attacks. It can also provide information about changes that affect migraine patterns.
• Exercise regularly. Exercise is often recommended as a health promotion activity, but migraine sufferers tend to exercise less than the general population, as they fear it might trigger a migraine. In fact, the stress reduction benefits of the exercise can positively influence migraine prevention.
• Utilize physical therapy and massages. Physical therapy helps migraine sufferers who frequently experience tension, stiffness and discomfort that are associated with migraines. Cervical region pain that occurs from trauma or sitting at a computer for long periods will tighten the area and can trigger migraines. Massage benefits for stress reduction and muscle relaxation, similar to physical therapy, can also have benefits that help reduce the potential migraine triggers.
• Consider alternative relief options. Yoga, acupuncture and essential oils are other options to help mitigate triggers. Acupuncture promotes blood flow in the tissues, which can help reduction muscle tension and mitigate triggers. Yoga has been found to reduce the number of migraine episodes and lessen the intensity with the recommendation of engaging in specific yoga poses for 30 minutes, five times per week. And essential oils can promote an improved quality of life with anti-inflammatory and relaxation properties.

A release from the FDA quotes Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, as saying,  “Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition.”

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. Approximately one-third of affected individuals can predict the onset of a migraine because it is preceded by an aura – transient sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks triggered by a number of different factors, including stress, hormonal changes, bright or flashing lights, lack of food or sleep and diet. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide.

The release explains that the effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials. The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo. Over the course of six months, Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo. The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo. Over the course of three months, Aimovig-treated patients experienced, on average, one fewer migraine day per month than those on placebo. The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo. In that study, over the course of three months, patients treated with Aimovig experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo.

The most common side effects that patients in the clinical trials reported were injection site reactions and constipation.

The FDA granted the approval of Aimovig to Amgen Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

An October 31^st 2016 release from the university reports that there are two different approaches to preventing headaches with diet. The first approach would be an elimination diet that avoids foods and beverages known to trigger headaches. The second approach would be to follow a comprehensive diet that may prevent headaches, explains Martin, co-director of the Headache and Facial Pain Center at UC Gardner Neuroscience Institute and an expert in the area of migraine. His conclusions and others come after performing an exhaustive literature review of more than 180 research studies on the subject of migraine and diet.

Martin’s two-part review, is publsihed online in the Headache: The Journal of Head and Face Pain. It is co-authored by Dr. Brinder Vij, associate professor in the UC Department of Neurology and Rehabilitation Medicine.

The release quotes Martin as saying, “One of the most important triggers for headache is the withdrawal of caffeine. Let’s say you regularly pound down three or four cups of coffee every morning and you decide to skip your morning routine one day, you will likely have full-fledged caffeine withdrawal headache that day.”

That said, too much coffee may also present a risk. No more than 400 milligrams daily–one cup is 125 milligrams–is probably the maximum for migraine patients, says Martin. “Large amounts of caffeine can bring on anxiety and depressive symptoms as well as headaches,” he explains.

Another trigger for migraine is MSG, which is a flavor enhancer used in a variety of processed foods, including frozen or canned foods, soups, international foods, snack foods, salad dressing, seasoning salts, ketchup, barbecue sauce, and heavily in Chinese cooking, says Martin.

“You eliminate it by eating fewer processed foods,” explains Martin. “You eat more natural things such as fresh vegetables, fresh fruits and fresh meats. MSG is most provocative when consumed in liquids such as soups.”

Nitrites are preservatives food in processed meats such as bacon, sausage, ham and lunch meat to preserve color and flavor. Martin says a diary study found that five percent of individuals with migraine were statistically more likely to have an attack on days when they consume nitrites. Use of nitrites in foods has declined with stronger government regulation though checking labels remains a good idea, he explains.

Alcohol is one of the most commonly reported dietary trigger factors for migraine and studies suggest vodka and red wines, especially those with highest histamine content are problematic, says Martin. There is a lot of interest in gluten-free diets, but they are only helpful in lessening headaches if the individuals suffer from celiac disease, which can be established by a positive blood test or intestinal biopsy, he adds.

There have been three comprehensive diets whose very composition may prevent headaches such as low fat and low carbohydrate diets as well as those that increase the amount of omega-3 fatty acids and decrease the amount of omega-6 fatty acids, according to Martin.

Vij says low fat diets restrict the amount of fat in the diet to less than 20 percent of your daily energy requirements. “The beauty of these diets is that they not only reduce headaches, but may produce weight loss and prevent heart disease”, says Vij.

Low carbohydrate diets such as ketogenic diets can reduce headache frequency, but it’s not something to consider without strict physician supervision. The diet limits carbohydrates more than the well-known Atkins diet, Vij explains.

One of the most promising diets for those with more frequent attacks of migraine is one that boosts your omega-3 fats while lessoning your omega-6 levels and that means tossing out polyunsaturated vegetable oils (corn, sunflower, safflower, canola and soy) in favor of flaxseed oil, says Martin. Foods to consume would include flaxseed, salmon, halibut, cod and scallops while those to avoid would be peanuts and cashews.

“Persons with headache and migraine have more dietary options than ever. Ultimately a healthy headache diet excludes processed foods, minimizes caffeine and includes a lot of fruits, vegetables, fish and lean meats”, Martin says. He adds, “After all, you are what you eat.”

A release from Thomas Jefferson University in Philadelphia notes that not only does the study suggest these drugs are safe for this subset of migraine patients, it could also have implications for the nearly 10 million migraine sufferers who experience auras – a disturbance in vision, touch, speech, thinking, or strength that usually precedes a migraine headache.

The release quotes senior author Brad Klein, M.D., Medical Director of the Headache Center at Abington Hospital-Jefferson Health, as saying, “There are not enough medicines out there to appropriately manage migraine headaches. At a time in history when an unprecedented number of people are getting hooked on narcotic opiates by way of prescribed medications – as is the case with migraine sufferers as well – we owe it to ourselves as physicians to try medications that could work without the risk of addiction.”

Migraines are thought to cause pain because they cause a swelling of the blood vessels feeding the brain. However, two subtypes of migraines, basilar and hemiplegic, are thought to cause pain by doing the opposite – constricting rather than swelling the blood vessels of the brain. Triptans and DHE are both thought to relieve migraine, in part, by constricting blood vessels. Early on, drug developers worried that adding more constriction to basilar and hemiplegic migraines could put these patients at greater risk of stroke, so these patients were excluded from the initial studies. “As a result,” says Klein, “no one ever actually showed that these drugs were dangerous – they were just assumed to be dangerous based on their mechanism of action. And recent research suggests that the auras are not due to blood vessel constriction.”

To determine whether there was any increased risk of stroke in basilar and hemiplegic patients taking triptans or DHE, Klein and researchers at Brigham and Women’s Hospital in Boston did a retrospective analysis, collecting data from four headache centers around the country. They searched for patients who had symptoms pointing to a basilar or hemiplegic migraine diagnosis and also received either a triptan or DHE treatment. Of the 80 patients they identified, they saw no cases of stroke or heart attack during the period of routine follow up, over several months.

Although others had studied this effect before, this research had the largest patient cohort to date, and was also one of the first to examine patients treated with DHE.

Migraines can be very complex to diagnose and there are few certified headache specialists in the United States – only 500 for the 38 million sufferers, according to the Migraine Research Foundation. “Because auras are associated with basilar and hemiplegic migraine, many physicians refuse to give these drugs to any patients experiencing an aura out of a false sense of precaution,” says Dr. Klein. Instead migraine sufferers may be given other, less effective drugs such as opioid narcotics.

The discovery was made by investigators at the University of Cincinnati (UC), Montefiore Headache Center, Albert Einstein College of Medicine and Vedanta Research.

“Women have been telling doctors that their migraine headaches worsen around menopause and now we have proof they were right,” says Vincent Martin, MD, professor of internal medicine in UC’s Division of General Internal Medicine and co-director of the Headache and Facial Pain Program at the UC Neuroscience Institute.

The risk for high frequency headache, or more than 10 days with headache per month, increased by 60 percent in middle-aged women with migraine during the perimenopause—the transitional period into menopause marked by irregular menstrual cycles—as compared to normally cycling women, says Martin, the study’s lead author.

The findings were published in Headache: The Journal of Head and Face Pain, a publication of the American Headache Society.

Martin teamed with Richard Lipton, MD, Jelena Pavlovic, MD, PhD, and Dawn Buse, PhD, from Montefiore Headache Center and Albert Einstein College of Medicine, and Kristina Fanning, PhD, and Michael Reed, PhD, from Vedanta Research, Chapel Hill, NC, to study 3,664 women who experienced migraine before and during their menopausal years.

The menopausal years include both the perimenopause and menopause. Menopause begins when women have not had a menstrual period for one year. Symptoms such as hot flashes, irritability, depression and insomnia are common during both.

“Changes in female hormones such as estrogen and progesterone that occur during the perimenopause might trigger increased headaches during this time,” says Richard Lipton, MD, director, Montefiore Headache Center and professor and vice chair of neurology, and the Edwin S. Lowe Chair in Neurology, Albert Einstein College of Medicine.

The risk of headache was most apparent during the later stage of the perimenopause, which is a time during which women first begin skipping menstrual periods and experience low levels of estrogen, adds Lipton, also lead investigator of the American Migraine Prevalence and Prevention (AMPP) Study.

Martin says women who participated in the study also reported that high frequency headache increased by 76 percent during menopause.  However, researchers think that it may not necessarily be the direct result of hormonal changes, but rather due to medication overuse that occurs commonly during this time.

“Women as they get older develop lots of aches and pains, joints and back pain and it is possible their overuse of pain medications for headache and other conditions might actually drive an increase in headaches for the menopause group,” says Martin, also a physician at UC Health.

Researchers identified the group of women aged 35 to 65 from the AMPP Study for the cross-sectional observational analysis. The AMPP Study is a longitudinal study where 24,000 people with severe headache were followed annually over six years.

About 12 percent of the U.S. population experiences migraine, with women suffering from them three times more frequently than men. For women approaching menopause and suffering from migraine there is help, explains Jelena Pavlovic, MD, PhD, co-author of the study, attending physician in neurology, Montefiore and assistant professor of The Saul R. Korey Department of Neurology, Einstein.

“Physicians can prescribe hormonal therapies that level out these changes that occur during the perimenopause and menopause time periods,” says Pavlovic. “If the patient is in early perimenopause, you can give birth control pills that level things out. If they are in the late perimenopause and they start skipping periods, they can be put on estrogen patches.”

The first week of this riddle, the patient reported her symptoms to her PCP. The doctor proceeded with the examination using the classic S-O-A-P notes as follows:

S=Symptoms or Chief Complaint

O=Objective Findings

A=Assessment or Analysis

P=Treatment Plan or Recommendations

The doctor recognized a potential medical emergency and transferred Chole to the Emergency Department immediately. Last week, we learned what happened when Chloe first arrived in the Emergency Department. This week, we’ll let you know what some people have suggested as possible diagnoses. Next week, the doctor will reveal the actual diagnosis. Then we’ll begin a new riddle for the following month!

Some Guesses as to What the Diagnosis Will Be

“Chloe’s doctor said she had normal blood pressure and pulse, so I guess he’s not worried about what my doctor called ‘pre-stroke’. I had ‘malignant hypertension’, meaning extremely high blood pressure that came on suddenly. They lowered it slowly over a matter of a few hours and I ended up with no organ damage and no stroke. That said, I still wonder if Chloe could have had a little stroke, what they call a transient ischemic attack or TIA. ”

— Julie R.

“Maybe Chloe has an aneurysm. I hope not because that wouldn’t be good news! A brain aneurysm is a bulging area in the wall of a blood vessel. The reason I know is that my brother who is about Chloe’s age had a brain aneurysm. It ruptured and bled and was a life-threatening emergency. His wife got him to urgent care immediately and he pulled through, but it was very frightening. We did learn, though, that many aneurysms don’t rupture and that there are treatments to keep them from rupturing.”

— Kay L.

“Could Chloe have a brain tumor? I imagine that the CT scan would show that. If she does have a tumor, I pray it’s not cancer! Of course even benign brain tumors can be dangerous, but a friend of mine had one and she had surgery to remonve the tumor. She’s hale and hearty four years later, thank goodness!”

— Marlene G.

“Is Chloe positive she never had unequal pupil size before she hit her head? Maybe she never really studied her eyes in the mirror before the headchaes started. I had an enlarged pupil that my eye doctor noticed. She said it was called benign anisocoria and I probably got it from stress. I had just gone trhough a divorce and we were in the middle of a custody battle. I ended up getting the kids. Eventually the anaocoria went away.”

— Susan F.

“Meningitis seems like a possibility to me, although a pretty remote one. Meningitis is an inflammation of the membranes around the brain and the spinal cord. Usually the cause is a viral infection. My daughter had it her freshman year of college. The symptoms were a lot like what Chloe describes. My daughter doesn’t remember hitting her head, though, so Chloe’s problems probably aren’t from an infection. Also, meningitis is most common in young adults, especially those who live in communal settings such as dorms. ”

— Deirdre M.

To be continued . . .

Come back to ThirdAge.com next Thursday when the doctor will reveal the actual diagnosis and treatment plan.

Marie Savard, M.D., a former Medical Contributor for ABC News and a frequent keynote speaker around the world, is one of the most trusted voices on women’s health, wellness, and patient empowerment. She is the author of four books, including one that made the Wall Street Journal list of the best health books of 2009: “Ask Dr. Marie: What Women Need to Know about Hormones, Libido, and the Medical Problems No One Talks About.” Dr. Marie earned a B.S. in Nursing and an M.D. degree at the University of Pennsylvania. She has served as Director of the Center for Women’s Health at the Medical College of Pennsylvania, technical advisor to the United Nations’ Fourth World Conference on Women in Beijing, advisor to the American Board of Internal Medicine Subcommittee on Clinical Competency in Women’s Health, health columnist for Woman’s Day magazine, and senior medical consultant to Lifetime Television’s Strong Medicine. Please visit DrSavard.com.

A release from the American Headache Society quotes Peter J. Goadsby, MD, PhD, chair of the scientific program of the American Headache Society’s 57th annual Scientific Meeting in Washington, D.C., as saying, “This development is a transformative moment in migraine treatment.” Dr. Goadbsy is Chief of the UCSF Headache Center, and one of the world’s leading headache treatment experts and researchers.

“There’s no question that we need something better. In fact, for prevention we really need something designed specifically for migraine,” he said, noting that there has not been a new class of anti-migraine drugs since the development and marketing of triptans in 1991 and they are not preventives, just designed to treat migraine attacks.

“Up till now, migraine patients have had limited choices for preventive treatment. Now four pharmaceutical companies are showing positive results in human trials targeting CGRP mechanisms,” he said. Scholarly papers on CGRP and on the trials were presented at the meeting in June 2015, which drew more than 1,000 migraine specialists from around the world.

The new class of therapeutic agents appears to reduce elevated levels of the peptide known as calcitonin gene-related peptide (CGRP), a key driver of migraine pain.

Versions of anti-CGRP therapies are being tested by Alder Pharmaceuticals, Amgen, Eli Lilly and Company, and Teva Pharmaceuticals.

In Phase IIb trials (studies conducted patients with migraine) data presented at the American Headache Society meeting by Teva reported for the first time that its drug, as a preventive treatment of high frequency episodic migraine, achieved a significant reduction in the number of headache hours after one week, with more than half of patients in each arm experiencing a 50% or greater reduction in headache frequency. Lilly presented, for the first time, Phase II data in episodic migraine that establishes the efficacy of their medicine against placebo with monthly administration across a range of doses. Amgen presented Phase II data for its anti-CGRP product that showed that the drug reduced the number of migraine days by 50% in about half the treated patients after 12 weeks. Alder Pharmaceutical, the fourth player in the CGRP race, is also developing an anti-CGRP drug with positive phase II data published, and did not present further data at the meeting.

“The potential of these new compounds is enormous and gives us real hope that effective specific treatments for migraine may be on the near horizon,” Dr. Goadsby said. “The development of CGRP antibodies offers the simple, yet elegant and long awaited option for migraine patients to finally be treated with migraine preventives; it’s a truly landmark development.”