Archive
New treatments

Zavegepant (Zavzpret), the first CGRP nasal spray for the treatment of acute migraine attacks, was approved by the FDA in March and is now readily available in all US pharmacies..

Zavegepant belongs to the family of CGRP antagonists, which work by blocking excessive amounts of the neurotransmitter CGRP. Elevated levels of CGRP are known to contribute to the development of migraines. By inhibiting its action, zavegepant can effectively stop an ongoing migraine attack. While there are already two oral CGRP medications for the acute treatment of migraines (Nurtec and Ubrelvy), zavegepant is the first nasal spray option. Nasal sprays offer several advantages, including faster onset of action compared to tablets and the ability to bypass the stomach. These benefits are particularly valuable for individuals experiencing migraines accompanied by nausea and vomiting.

Clinical studies have demonstrated that zavegepant is superior to placebo in promptly eliminating all pain and the most bothersome symptom within two hours of administration. The most commonly reported bothersome symptoms associated with migraines are nausea, sensitivity to light (photophobia), and sensitivity to noise (phonophobia).

Side effects of zavegepant were generally mild and infrequent. Participants in clinical trials noted an unpleasant taste in 18% of cases, compared to 4% in the placebo group. Additional side effects included nausea (4% vs. 1%), nasal discomfort (3% vs. 1%), and vomiting (2% vs. 1%). Taste-related issues have been observed with other nasal sprays used for migraines, particularly among patients who experience nausea. However, this can be easily addressed by sucking on a hard candy while using the nasal spray.

Interestingly, even individuals who did not respond to other CGRP drugs may potentially benefit from zavegepant. While these drugs are similar in their mechanism of action, they are not identical, and patients often exhibit strong preferences for a particular medication within the same category. This preference phenomenon is common in other migraine drug categories such as triptans, NSAIDs, and oral CGRP drugs.

Read More

Our research at the New York Headache Center and that of many of our colleagues, as well as the clinical experience of doctors and thousands of patients, have proven the role of magnesium in treating migraine headaches. I’ve written many blog posts on the role of magnesium in a wide variety of other medical conditions.

A new report in the European Journal of Nutrition suggests that dietary intake of magnesium is related to the size of the brain.

This study looked at how the amount of magnesium in people’s diets is related to the size of their brains and the presence of white matter lesions (which are abnormalities in the brain seen on the MRI scan) as they get older. The researchers used data from 6,000 middle-aged to older adults in the UK. They measured magnesium intake through a questionnaire and used statistical models to analyze the data.

The results showed that people who had higher magnesium intake generally had larger brain volumes, including the gray matter and specific areas called the left and right hippocampus. When they looked at different patterns of magnesium intake over time, they found three groups: one with high magnesium intake that decreased over time, one with low magnesium intake that increased, and one with stable and normal magnesium intake. In women, those in the high-decreasing group had larger brain volumes compared to the normal-stable group. On the other hand, women in the low-increasing group had smaller brain volumes and more white matter lesions.

The researchers also looked at the relationship between magnesium intake and blood pressure, but the results were not significant. Additionally, they found that the positive effect of higher magnesium intake on brain health was more pronounced in women who had gone through menopause.

In conclusion, having a higher intake of magnesium in the diet is associated with larger brain volumes.

Omega-3 fatty acids have also been shown to have a positive effect on brain volume in older adults.  

Vitamin B12 is another nutrient that is probably involved in preserving brain volume. 

Multiple studies have shown that meditation is associated with larger brain volumes. 

Exercise is also a proven way  to prevent cognitive decline.

All these interventions have no side effects and I would recommend them to everyone regardles of age.

Read More

Thank you, Lisa Robin Benson for a kind review of my book. This is a video review on the Migraine.com website.

Many of my colleagues have written very positively about my book. It is even more gratyfing to hear that patients and patient advocates also find it useful.

Read More

Opportunities & Challenges in the Management of Headache is one of the two annual courses organized by the Diamond Headache Clinic Research & Educational Foundation. This year, it will be held in San Diego from February 16th through February 19th.

The other annual event, Headache Update 2023 will be held in Orlando, Fl from July 13th through July 16th. Both courses have been always well attended and have been receiving very high marks from the attendees.

It’s been my privilege to participate in these annual courses over the past 25 years. This year I will be speaking on February 17th on Nutritional Approaches and Alternative Therapies in Migraine.

Read More

It was an honor to speak in Israel at the 6th Annual International Headache Symposium along with past presidents of the International Headache Society, Drs. Messoud Ashina and Alan Rapaport, the current IHS president, Cristina Tassorelli, the president-elect, Dr. Rami Burstein, and other leading headache experts. The symposium was organized by the President of the Israeli Headache Association, Dr. Oved Daniel, and by Dr. Arieh Kuritzky.

 

Read More

No, Daxxify is not really a competitor in the treatment of chronic migraines or any other medical condition. Daxxify, a new botulinum toxin, was just approved by the FDA only for cosmetic use. Daxxify does stand out from five other botulinum toxin brands in that its effect lasts longer. The other toxins are Xeomin, Dysport, Jeuveau, and Myobloc. Myobloc is approved only for medical conditions, Jeuveau only for cosmetics, and Xeomin and Dysport are approved for both cosmetics and a few medical conditions.

Initially, Botox was approved by the FDA in 1989 to treat eye problems. Since then, it has been approved for many medical and cosmetic indications, including chronic migraine. None of the other toxins are approved for such a wide range of indications. It remains by far the most widely used type of botulinum toxin with tens of millions of people treated for medical and cosmetic reasons.

Yes, having a longer-acting botulinum toxin is an advantage. You will need to have less frequent treatments. However, if you have any side effects, they will also take longer to go away. We are talking mostly about cosmetic side effects, such as droopy eyelids. When treating headaches, with proper technique, side effects are uncommon. These may include weakness of the neck muscles or, if treating TMJ syndrome, difficulty chewing.

Since Botox is approved by the FDA for chronic migraines, Botox is the drug insurance companies cover. Allergan (a division of Abbvie), the manufacturer of Botox, has many more years left on their patent to treat chronic migraines. Botulinum toxin is a biological product (made by bacteria rather than synthesized from chemicals) and every version of it is slightly different. This is why when Allergan’s patent to treat migraines expires, the competitors will have to conduct large trials to prove that their product is also effective for migraines.

Read More

A case report presented at the annual meeting of the American Headache Society described a patient with trigeminal neuralgia (TN) whose pain responded well to rimegepant (Nurtec). Rimegepant is a drug approved for the acute and preventive treatment of migraines. This patient did not obtain relief from surgery and several medications. He was taking 300 mg of oxcarbazepine, buprenorphine (narcotic) patch, and up to 120 mg of oxycodone with partial relief. Within 12 hours of starting rimegepant he was pain-free. In the six months of taking rimegepant he experienced very infrequent and mild pain.

There have been several reports indicating that injections of CGRP monoclonal antibodies such as erenumab can relieve the pain of TN. So it is not surprising that an oral CGRP drug helped this patient.

I’ve treated several TN patients with CGRP antibodies. One such patient has been receiving injections of galacanezumab for over 3 years. He requires injections of 240 mg every 3 weeks and also has to take daily medications. This combination has allowed him to be fully functional and to keep his job. I may now try him on an oral CGRP drug.

In addition to rimegepant, there are two other oral CGRP drugs – ubrogepant (Ubrelvy) and atogepant (Qulipta). They are very similar but many patients have a clear preference for one over the others. It may be worth trying them all if the first drug is not fully effective. A major obstacle to using these medications “off label” for TN is their high cost.

Read More

Not surprisingly, none of the new migraine drugs have been tested in pregnant women. No new drug for any indication is ever tested for its safety in human pregnancy. They are always tested in pregnant animals, which helps weed out most drugs that are clearly dangerous. It takes decades to learn if a drug is safe. This happens through an accumulation of anecdotal reports and pregnancy registries that are usually run by drug manufacturers.

Erenumab (Aimovig) was the first CGRP monoclonal antibody to be approved for the preventive treatment of migraines four years ago. It was tested in pregnant monkeys who were given 50 times higher doses (by weight) than the FDA-approved dose for humans. Even though some of the medicine crossed the placenta into baby monkeys, they had no developmental problems.

In the current issue of Headache, University of Texas doctors published a report of a woman who continued to inject herself with erenumab throughout the duration of her pregnancy. She tried to stop the drug before planning to get pregnant but her severe migraines recurred. Her baby was born healthy and had normal development by the last evaluation at 6 months of age.

This case report is the first very small but important step in the process of evaluating the safety of erenumab in pregnancy.

In humans, the transfer of antibodies, which are large molecules, across the placenta is very limited before the 16th week of pregnancy and increases after the 22nd week. We still recommend stopping the drug about five months before a pregnancy is planned. If a woman, however, does get pregnant, intentionally or not, the risk of complications is low if erenumab is stopped within the first three months of pregnancy. This also applies to all other monoclonal antibodies in general and specifically other migraine drugs – galcanezumab (Emgality), fremanezumab (Ajovy ), and eptinezumab (Vyepti).

Read More

Yesterday I saw a 48-year-old man who has been suffering from migraine headaches since his teens. He did not respond to a wide variety of drugs and non-drug therapies, but Emgality has been very effective. The only problem is that the effect lasts three and a half weeks. During the week before the next shot, his migraine headaches become severe and frequent. Sumatriptan helps but his disability as measured by the MIDAS scale is in the moderate range. He is a high-level executive in a large corporation and needs better control of his migraines. He had tried the other two monoclonal antibodies for migraines – Aimovig and Ajovy – and they were less effective.

Fortunately, there is a good solution to his problem. I advised him to take Emgality injections every three and a half weeks. This is a higher frequency than what is recommended by the FDA and some doctors and patients may have concerns about the safety. The one-month interval is based on averages derived from large studies. People, however, are not average. Some metabolize drugs faster or need a higher or a lower dose of a drug. Another reassuring fact about Emgality is that it is approved at a much higher dose for cluster headaches. For migraine, we give a 240 mg loading dose and then, 120 mg monthly. Patients with cluster headaches get monthly injections of 300 mg.

I have patients who have the same problem of the short duration of effect with Aimovig and Ajovy as well.

A major obstacle to the more frequent use of these drugs is the fact that insurance companies will only pay for 12 shots a year. These drugs cost about $600 to $700 a dose, so the cost is a major factor for many people. The way I get around it is by providing patients with free samples. Because we have three similar competing drugs, we get samples of all three. If you are having a similar problem, ask your doctor for a free sample. Some academic centers and large hospitals do not allow doctors to receive samples but most doctors in private practice can get them.

Read More

I am honored to speak (in person) at this patient advocacy event. My topic will be, When treatments stop working, what’s next?

Here is some information and a link:

RetreatMigraine 2022: April 1-3 at Hilton Charlotte University Place
RetreatMigraine is a conference specially designed by and for adults living with migraine disease. The multi-day event brings together patients, care partners and migraine experts to support and strengthen our community. In 2022 RetreatMigraine will be a hybrid event. In-person capacity is for 300+ attendees and virtual capacity is unlimited. The conference offers interactive sessions that provide disease and treatment education, advocacy training and complementary therapy experiences.
This conference is organized by CHAMP – Coalition for Headache and Migraine Patients.

Read More

Nerivio, an electrical stimulation device was cleared by the FDA to treat acute migraine attacks in adults almost three years ago. It was recently also cleared to treat migraines in adolescents. A new study sponsored by Theranica, the manufacturer of Nerivio shows that combining this device with relaxation and education improves its efficacy.

Remote electrical neuromodulation (REN) is the official term for passing an electrical current through the arm in order to treat migraine headaches. Theoretically, other painful conditions can be also treated by electrical stimulation applied outside of the area of pain. Currently, however, there is only only one such device, Nerivio, and it is used to treat migraine headaches.

I’ve prescribed this device (and it still needs a prescription) to hundreds of patients. About half of them find it effective and continue using it. Some of my patients have remarked that not only their migraine improves, but they also feel more relaxed. I was a bit surprised because they are supposed to crank up the current to the point just below where it becomes painful. But even if you don’t feel relaxed, it makes sense for all patients to try to relax during this treatment which typically takes 45 minutes.

Theranica sponsored a trial that combined electrical stimulation with what they call Guided Intervention of Education and Relaxation (GIER). This consisted of a 25-minute video played on the user’s smartphone during the treatment. It trains patients in three relaxation techniques: diaphragmatic breathing, progressive muscle relaxation, and guided imagery. It also provides pain education about migraine biology and electrical stimulation.

The results of this trial were just published in the journal Pain Medicine. The lead author, Dr. Dawn Buse is a psychologist and one of the leading headache researchers.

The results in the group that used only Nerivio were consistent with those found in previous controlled trials – 57% of patients had consistent pain relief in more than 50% of their attacks, 20% had complete elimination of pain, 53% had improvement in function, and 18% were able to return to normal functioning within 2 hours after treatment.

Patients who combined Nerivio with GIER did better. 79% had pain relief, 71% had improved functioning, and 38% returned to normal functioning.

Nerivio is used through an app that is downloaded into a smartphone. This gives the company a perfect opportunity to easily enhance the efficacy of its product.

Read More

Cluster headaches are considered to cause the worst pain imaginable. We have a variety of medications – both acute and preventive – that help relieve the pain of cluster headaches. For some, none of these treatments work and we do need additional medications. Ketamine could be one such drug.

Ketamine has been in use for over 50 years. Its main indication is intravenous anesthesia. Recently, the FDA approved ketamine nasal spray for depression. It is also being widely used intravenously and by mouth for depression, chronic pain, and migraine headaches. A group of researchers at the Danish Headache Center in Glostrup, Denmark tested the efficacy of ketamine nasal spray for the acute treatment of cluster headaches.

Anja Petersen and her colleagues selected 20 cluster patients whose attacks did not respond sufficiently well to sumatriptan or oxygen – the two most effective acute therapies for cluster headaches. Patients treated a single cluster attack with 15 mg of intranasal ketamine. They could repeat this dose every 6 minutes, for up to 5 times. Four patients took another medication after 15 minutes. Of the 16 remaining ones, 11 had a drop in pain severity by an average of four points, to four or lower on a one to 10 scale. Half of the patients preferred ketamine to oxygen and/or sumatriptan injection. No patient had any serious side effects from ketamine during the trial.

Ketamine nasal spray that is approved for depression is a more potent version of ketamine called esketamine (Spravato). It is a patented and branded product and it is very expensive. Ketamine itself, however, is a cheap drug. A compounding pharmacy can prepare a nasal spray for as little as $60 for a month supply. Most insurers do not cover compounded drugs, so you’d have to pay for it.

Read More