Nasal spray to treat migraines

This article explains a nasal spray being developed to treat migraines.

Scientists from Nevada's Roseman University of Health Sciences presented their work on a nasal spray formulation of the antipsychotic prochlorperazine for the treatment of migraines at the American Association of Pharmaceutical Scientists annual meeting in San Diego.

"Prochlorperazine is a dopamine receptor antagonist that is widely used as an anti-nausea medication," said Venkata Yellepeddi, assistant professor of pharmaceutical sciences at Roseman University, in a statement. "Comparative clinical studies have shown that prochlorperazine provides better pain relief than other anti-migraine drugs such as sumatriptan, metoclopramide and ketorolac. Currently, there are no marketed nasal spray formulations of prochlorperazine available for the treatment of migraine. Prochlorperazine is only available in tablet form, which has delayed onset of action."

According to the FDA and the National Institutes of Health's medicine library, the generic drug prochlorperazine maleate is available in tablet form from Sandoz, the generics unit of Novartis, and Teva for the treatment of severe nausea and vomiting, schizophrenia and the short-term treatment of generalized nonpsychotic anxiety.

The Roseman University team hypothesizes that the reformulation will be effective, fast-acting and improve patient adherence, according to the release. It also avoids side effects associated with the use of preservatives.

Using high-performance liquid chromatography and microbiological assays, Yellepeddi showed that the nasal spray remained stable for up to 120 days, according to the release. Next, he will test the safety, efficacy and pharmacokinetics of the spray in rats. His research is being funded by a grant from the International Academy of Compounding Pharmacists Foundation.

While Yellepeddi's research is still in the early stages, in June, Avanir Pharmaceuticals touted positive results from a Phase III trial of its AVP-825 sumatriptan intranasal powder for migraines as compared with an oral formulation of the same treatment.

- read the release

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New noninvasive device for migraines - Using Cefaly in The Office to Treat Headaches.

A new noninvasive device has been developed to treat migraine headaches.

I have been very impressed so far. - JR

Two new prescription devices approved by the U.S. Food and Drug Administration (FDA) may provide some relief for people with migraine headaches who don't tolerate migraine medications well, according to a new study.

One device -- the Cefaly -- is designed to prevent migraines, while the other device -- the Cerena -- is meant to be used when migraines first start, according to an FDA news release.

"Patients have been looking for alternative migraine treatments. Because these devices aren't ingested or metabolized like drug therapies, they don't necessarily have the same types of side effects," Michael Hoffmann, a biomedical engineer with the FDA, said in the news release.

Migraines involve severe pulsing or throbbing pain in one part of the head. These intense headaches can also cause people to develop nausea and vomiting as well as sensitivity to light and sound. About one-third of people with migraines experience an aura, or visual effects such as flashing lights, dots or a blind spot, which marks the onset of the headache, said the FDA.

Migraines can last as long as 72 hours if left untreated. These headaches affect 37 million people in the United States. Although anyone -- even children -- can get migraines, women are affected more often than men, the FDA reported.

"There are many drugs to reduce migraine pain and symptoms," said Dr. Eric Bastings, a neurologist with the FDA, in the news release. "Although these drugs are quite effective, they are not for everyone. Some can make you tired, drowsy or dizzy. Some can affect your thinking. And some migraine drugs can cause birth defects; so pregnant women can't use them," he said.

The Cerena Transcranial Magnetic Stimulator can be used as soon as patients feel a migraine coming on. It's held against the back of the head. After pressing a button, a very short magnetic pulse stimulates the area of the brain that processes visual information, the FDA said.

The Cefaly transcutaneous electrical nerve stimulation device is also FDA-approved as a preventative treatment for migraine. Patients can use this device daily before a migraine develops. This portable, battery-powered device involves an electrode patch that is placed on patients' foreheads. The patch is connected to a headband. The device sets off an electrical current to stimulate a large nerve in the head that has been linked to migraines, the agency said.

"It's a set-time therapy -- running for 20 minutes and stopping automatically," Hoffmann noted.

Reported side effects for both devices were minor and resolved quickly, including:

• Skin irritation
• Discomfort
• Sleepiness
• Dizziness
• Pain at site of application

The FDA researchers noted the safety and effectiveness of the Cerena and Cefaly have not been evaluated in use by children, pregnant women and those with pacemakers.

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Study: Cognitive behavioral therapy can help kids with migraines

A study shows that symptoms of chronic migraines in children are reduced with cognitive behavioral therapy (CBT).

Among children and adolescents with chronic migraine, the use of cognitive behavioral therapy (CBT) resulted in greater reductions in headache frequency and migraine-related disability compared with headache education, according to a study appearing in the December 25 issue of JAMA.

"In adults, more than 2 percent of the population has chronic migraine and in children and adolescents the prevalence is up to 1.75 percent. In pediatric patients who seek care in headache specialty clinics, up to 69 percent have chronic migraine; however, there are no interventions approved by the U.S. Food and Drug Administration for the treatment of chronic migraine in young persons. As a result, current clinical practice is not evidence-based and quite variable," according to background information in the article.

Scott W. Powers, Ph.D., of Cincinnati Children's Hospital Medical Center, and colleagues randomized 135 participants (79 percent female) 10 to 17 years of age diagnosed with chronic migraine (≥ 15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points (disability score range: 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe) to CBT (n = 64) or headache education (n = 71). The study was conducted in the Headache Center at Cincinnati Children's Hospital between October 2006 and September 2012; 129 participants completed 20-week follow-up and 124 completed 12-month follow-up. The interventions consisted of 10 CBT or 10 headache education sessions involving equivalent time and therapist attention; CBT included training in pain coping, modified to include a biofeedback component. Each group received amitriptyline; follow-up visits were conducted at 3, 6, 9, and 12 months.

On average, at the beginning of the trial, participants reported 21 of 28 days with a headache and a PedMIDAS of 68 points, indicating a severe grade of disability. From pretreatment to posttreatment, CBT resulted in a decrease of 11.5 headache days vs. 6.8 days with headache education. At 12-month follow-up, 86 percent of CBT participants had a 50 percent or greater reduction in days with headache vs. 69 percent of the headache education group; 88 percent of CBT participants had a PedMIDAS of less than 20 points (mild to no disability) vs. 76 percent of the headache education group.

"Now that there is strong evidence for CBT in headache management, it should be routinely offered [to younger people] as a first-line treatment for chronic migraine along with medications and not only as an add-on if medications are not found to be sufficiently effective. Also, CBT should be made more accessible to patients by inclusion as a covered service by health insurance as well as testing of alternate formats of delivery, such as using online or mobile formats, which can be offered as an option if in-person visits are a barrier," the authors write.

System barriers may affect the likelihood of CBT being implemented as a first-line treatment for pediatric chronic migraine, writes Mark Connelly, Ph.D., of Children's Mercy Hospitals and Clinics, Kansas City, in an accompanying editorial.

"Creative means of delivering CBT for pediatric chronic migraine (e.g., via telehealth or Internet-based programs, using behavioral health consultants in primary care offices) will be necessary for reducing current access and referral barriers that could be encountered by many families and physicians. Widening the availability of interdisciplinary models of training and treatment delivery also will be important for helping ensure that children with chronic migraine routinely receive combination therapies rather than being referred for psychological therapy only after other approaches fail."

"Ideally with the efforts of the health care community and other relevant stakeholders, the suggestion by Powers et al to consider CBT along with medication as a first-line treatment for chronic migraine in children will be implemented into practice well before the typical translation gap. Additional studies are warranted, however, to identify methods of preventing chronic migraine development and to determine the medications and combination therapies that further maximize improvements in health and quality of life outcomes for children and adolescents with chronic migraine."

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How Botox can help with Cluster Headaches

This article discusses research that is currently being done to turn Botox into a treatment for cluster headaches.

Botox is best known as a facial wrinkle remover, but if all goes well with the research, someday soon it may be a treatment option for cluster headache. At least that is the hope of a team of scientists at the Norwegian University of Science and Technology (NTNU).

Why Botox?
Botox (onabotulinumtoxinA) is a neurotoxin and a drug that uses a potent poison called botulinum toxin, which is derived from the bacterium Clostridium botulinum. When it is injected into facial muscles, it paralyzes them temporarily and causes wrinkles to disappear for several months.

Similarly, injections of the toxin are used to block nerve signals that cause muscles contractions in cerebral palsy and bladder spasms, to block postsurgical pain and foot pain, and to temporarily relax eye muscles in people with strabismus (misaligned eyes). Botox also is sometimes used to treat migraine.

Cluster headache and Botox
Cluster headache pain is more severe than migraine pain and can drive patients to perform desperate acts, even suicide, to avoid it. Therefore finding effective treatments for this devastating condition, which affects an estimated 53 people per 100,000 per year, is essential.

That’s why Erling Tronvik, NTNU senior consultant and researcher, along with two colleagues, are about to undertake a study of the impact of Botox on cluster headache sufferers. This team has devised a treatment device that will allow them to shoot Botox through a hole in the nasal wall into a nerve bundle located behind the sinuses.

Clinicians will use magnetic resonance imaging (MRI) scans to accurately identify the location of the nerve bundle in each patient before treatment is initiated. According to Tronvik, this unique approach should (in theory) reduce or eliminate the flow of signals in this area for three to eight months, after which time patients would need to get another treatment.

“We designed the equipment ourselves, and Botox has never been used for this anywhere else,” noted Tronvik. Soon, 10 patients will enter the first pilot study of this treatment method.

If the results of the pilot study are positive, the team plans to enroll 30 to 40 patients who suffer with cluster headache and about 80 migraineurs as well.

Are there any side effects? Tronvik explained that use of MRI is a highly accurate way to locate the exact spot to inject the Botox. However, he also noted that if the toxin were to slightly miss the mark, patients could experience a weakened ability to chew or temporary double vision.

In the meantime, there’s some good news regarding chronic migraine. Botox has been shown to be helpful in relieving chronic migraine, as seen in the results of the PREEMPT (Research Evaluating Migraine Prophylaxis Therapy) clinical program.

In that study, nearly 70 percent of patients treated with Botox experienced at least a 50 percent reduction in the frequency of headache days. Other research has shown Botox to be effective as preventive treatment for chronic migraine and to provide a reduction in severity and intensity of pain as well as the number of days with disability.

If you suffer with cluster headache, a new effective treatment can’t come soon enough. Hopefully Botox or another option in the pipeline will prove beneficial in the near future.

Study References
Alvaro-Gonzalez LC et al. Botulinum toxin A in chronic refractory migraine: premarketing experience. Revista de Neurologia 2012 Oct 1; 55(7): 385-91
Aurora SK et al. OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurologica Scandinavica 2014 Jan; 129(1): 61-70

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Long-term treatment for headache sufferers

Electric stimulation of the peripheral nerve has shown long-term effectiveness for reducing the intensity of headaches for chronic headache sufferers.

For the more than 45 million Americans who suffer from chronic headaches, relief may be on the way in the form of an electric pulse, according to a study presented at the ANESTHESIOLOGY™ 2013 annual meeting. Electric stimulation of the peripheral nerve reduced average headache intensity by more than 70 percent.

With electric stimulation of the peripheral nerve, a thin insulated wire is implanted in the back of the head (occipital nerve) or in the forehead above the eyebrow (supraorbital nerve) and delivers electric pulses to block pain. The study looked into the safety and long-term usefulness of this treatment.

"Despite advances in headache treatment over the past two decades, many people do not get adequate pain relief from current treatments, or they cannot tolerate the side effects of the medications," said Billy K. Huh, M.D., Ph.D., professor and medical director of the Department of Pain Medicine at The University of Texas MD Anderson Cancer Center, Houston, and adjunct professor of the Department of Anesthesiology at Duke University Medical Center, Durham, N.C. "This treatment offers hope to those patients and a chance for a major improvement in quality of life."

The study monitored 46 patients who received peripheral nerve stimulation between 2005 and 2012. Follow-up phone interviews were conducted to determine subsequent headache intensity, frequency of headaches per month, complications and overall satisfaction with the treatment.

The study found that both headache intensity and frequency decreased significantly. The average headache intensity was reduced by more than 70 percent. The average number of "headache days" decreased from 28 to 14 per month. Ninety percent of patients were satisfied with the treatment, with one reporting more than eight years of reduced headache intensity and frequency.

A drawback of the treatment is its relatively high level of complications, which include electrode migration, equipment problems and infection. The study authors state that as physicians gain experience with implantation techniques, complications will decrease.

"This is a real breakthrough for chronic headache sufferers," explained Dr. Huh. "For patients with no other options to relieve their pain and suffering, this treatment is a way for them to get their life back."

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