Nasal Spray Approved for Migraine in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a nasal spray for the treatment of migraine in pediatric patients, the second migraine drug the agency has approved in the last month for patients 12 years of age and older.

About one in five teens suffer from migraine, but treatment options for them have been very limited compared to adults.

Zomig nasal spray was first approved by the FDA in 2003 for the treatment of migraine in adults. It provides pain relief in as little as 15 minutes, with most patients obtaining some relief in about two hours.

The FDA’s approval came after the agency reviewed safety and efficacy data from clinical trials demonstrating that Zomig was significantly more effective than placebo in relieving headache pain and other migraine symptoms in pediatric patients. It also had a safety profile similar to that in adults.

Zonig is the first prescription nasal spray approved for migraine in children. The most common adverse reaction to Zomig in pediatric patients during clinical trials was an unusual taste.

"Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making Zomig Nasal Spray available to this 'school age' patient population," said Fred Wilkinson, President and CEO of Impax Laboratories, which obtained the U.S. commercial rights to Zomig products from AstraZeneca in 2012. Impax has since lost exclusive rights to Zonig tablets and is focused on the nasal spray.

The recommended starting dose for Zomig in pediatric patients is 2.5 mg. The dosage can be adjusted on an individual basis, but should not exceed 5 mg in a single dose or a maximum daily dose of 10 mg in any 24 hour period.

Last month the FDA approved the migraine drug Treximet for pediatric patients 12 years of age and older.. Treximet is the first approved combination drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

Like Zomig, Treximet had already been on the market for several years to treat migraine in adults.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

The month of June is Migraine Awareness Month.

Back Pain World's Leading Cause of Disability

By Pat Anson, Editor

Lower back pain remains the world's leading cause of disability, according to an extensive new study of health data that also warns that the number of people living in poor health is set to rise rapidly over coming decades.

Using a statistical analysis known as "years lived with disability" (YLD),  the Global Burden of Disease Study ranks lower back pain as the leading cause of disability worldwide, followed by major depression.  

Low back pain was the leading cause of YLDs in 86 countries and the second or third leading cause in 67 countries. It also caused more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined.

Several other painful conditions also ranked high, including neck pain (#4), migraine (#7),  musculoskeletal disorders (#10), osteoarthritis (#13) and medication overuse headache (#18).

The study, which is published online in The Lancet, is the first to examine the extent, pattern, and trends in disabilities worldwide. An international consortium of researchers led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington studied 301 diseases and injuries in 188 countries.

They found that while people around the world are living longer, they are spending more time in ill health as rates of diseases and injuries decline more slowly than death rates.

Just one in 20 people worldwide had no health problems in 2013, with a third of the world’s population -- 2.3 billion people -- experiencing more than five ailments. Of those, 81% were younger than 65 years old.

The disease burdens for low back pain and depression both increased more than 50% since 1990. There was also a startling increase in disability caused by diabetes (up 136%), Alzheimer’s disease (up 92%), medication overuse headache (up 120%), and osteoarthritis (up 75%).

"What ails you isn't necessarily what kills you," said IHME Director Dr. Christopher Murray. "As nonfatal illnesses and related ailments affect more people of all ages, countries must look closely at health policies and spending to target these conditions."

Between 1990 and 2013, YLDs increased from 537.6 million to 764.8 million for both sexes. The leading causes of YLD remained largely stable during this period, but they took an increased toll on health due to population growth and aging.

Musculoskeletal disorders, combined with fractures and soft tissue injuries, accounted for one-fifth of YLDs globally in 2013, ranging from a low of 11% for Mali's population to a high of 30% in South Korea.

"Many countries around the world have made great progress in addressing fatal diseases, but nonfatal illnesses pose the next major threat in terms of disease burden," said Professor Theo Vos of IHME, the study's lead author. "This need to meet the challenge of nonfatal diseases and injuries only becomes more urgent as the population increases and people live longer."

Leading Causes of YLDs in 2013:

1.  Low back pain
2.  Major depressive disorder
3.  Iron-deficiency anemia
4.  Neck pain
5.  Hearing loss
6.  Diabetes
7.  Migraine
8.  Chronic obstructive pulmonary disease
9.  Anxiety disorders
10.  Other musculoskeletal disorders

“Large, preventable causes of health loss, particularly serious musculoskeletal disorders and mental and behavioral disorders, have not received the attention that they deserve. Addressing these issues will require a shift in health priorities around the world, not just to keep people alive into old age, but also to keep them healthy,” said Vos.

This study was funded by the Bill & Melinda Gates Foundation.

Fatigue Often Stops RA Patients from Working

By Pat Anson, Editor

Fatigue and pain are the top reasons rheumatoid arthritis (RA) patients in the U.S. stop working, according to a new survey that found only about a third of RA patients are still employed full-time.

The “RA in America” survey of over 3,500 patients was conducted online by Health Union, a healthcare research and marketing company. It found that RA had a severe impact on patients’ quality of life, employment, and ability to afford treatment.

RA is a chronic and disabling autoimmune disease that causes pain and stiffness in joints. It affects about 1.3 million Americans and about one percent of the global population.

Ninety-four percent of respondents said they cannot do as much as they were able before acquiring the disease. Only 37% said they were still working full time.

Although fatigue is often overlooked as a symptom of RA, it had the greatest impact on the respondents’ ability to work – with 92% reporting they were tired while on the job. Pain, physical limitations, and a lack of understanding by colleagues also presented challenges.

“My biggest complaint is fatigue,” wrote one poster on a Health Union Facebook page.  “I am an invalid due to RA. I am in bed 24/7, I can't even sit up. I sleep a lot, not much else to do, but no matter how much I sleep, when I wake I'm exhausted. It's so crazy. I can sleep for 20 hours, and I'm exhausted the minute I open my eyes.”

“I was forced from my job because of exhaustion,” wrote another woman. “The meds contributed to the sleepiness, so I am careful about which I take. (I have) developed Lupus, OA and several related syndrome in addition to the RA.”

Many people who were surveyed said they were diagnosed with other conditions, including depression and anxiety (39%), high blood pressure (33%), fibromyalgia (32%) and migraine (25%).

Survey respondents also reported they needed help with daily activities, such as cleaning (75%) and other household chores (52%). Over a third (41%) needed assistance from a caregiver, which was typically a spouse, to help manage their RA.

"Many people do not know rheumatoid arthritis is a progressive, autoimmune disease and not the result of aging and wear on the body, like osteoarthritis the most common form of arthritis," said Andrew Lumpe, PhD, an RA patient. "Treatment can help slow the damage, but rheumatoid arthritis frequently alters the lives of both patients and their families."

The survey found some good news to report. Over a third (34%) of respondents said their RA had gone into remission at some point, usually for less than a year. Nearly three-fourths (74%) said the remission occurred after they began taking medication.

About half the survey respondents reported satisfaction with their treatments and only 21% were dissatisfied. Those on biologics, a newer and more expensive medication that can cost over $20,000 a year, had a slightly higher satisfaction rate. Over a third of respondents (38%) have avoided medications because of cost.

"The affordability of effective rheumatoid arthritis treatments is a serious concern," said Mariah Leach, an RA patient. "When you consider the burden this disease places on patients in terms of quality of life and employment, it is clear that supporting these individuals with treatment options can yield many benefits."

FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Nerve Stimulation Effective in Treating Cluster Headache (VIDEO)

By Pat Anson, Editor

A neuromodulation device that stimulates a nerve in the neck substantially reduced the number and frequency of attacks in patients suffering from cluster headache, according to small study published in the journal Neurology. 

Image courtesy of electrocore

Seventy-nine percent of patients who completed the study (15 out of 19) reported an overall improvement in their condition after using gammaCore, a nerve stimulator that sends electrical signals along the vagus nerve, which runs through the neck to the brain. Eleven of the patients had chronic cluster headaches, and eight were classified as episodic.

“Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.” said Peter Goadsby, PhD, who led the research at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.

Cluster headache is a neurological disorder characterized by recurring, severe headaches on one side of the head, often around the eye. Attacks occur suddenly and can range from 15 minutes to three hours. Recommended treatments for cluster headaches include oxygen or triptan. 

Nearly half (47%) of the acute attacks treated with gammaCore ended in an average of 11 minutes.  Ten patients reduced their use of oxygen by 55% and nine patients reduced their triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in the frequency of attacks, from 4.5 attacks every 24 hours to 2.6 after treatment. 

The treatment, which is self-administered by the patient for two minutes, involves placing the hand-held gammaCore device on the skin of the neck over the vagus nerve. In the study, patients administered two to three rounds of neurostimulation twice per day. Acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious side events.

GammaCore, which is manufactured by New Jersey based electroCore, is not currently approved by the Food and Drug Administration and is not available in the United States. 

The company is seeking FDA approval for gammaCore in the treatment and prevention of cluster headache. The device currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada. 

“It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a substance, called glutamate, that has been associated with headache symptoms,” the company says in a statement on its website.

ElectroCore is developing Vagus Nerve Stimulation (nVNS) therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders.

ElectroCore has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.