Innovating Neuroscience NuPathe Blog

Calling for Congressional Hearings on the Impact of Migraine and Other Headache Disorders

2012-01-12T00:00:00-05:00

In the U.S. alone, 31 million adults—or 12 percent of the population—suffer from migraine. Currently, National Institutes for Health funding for migraine and other headache disorder research is less than half of 1 percent of the agency’s budget.

The non-profit Alliance for Headache Disorders Advocacy was founded to work to increase research into new and better treatments specifically for migraine and other headache disorders. As a first step, the Alliance is petitioning Congress to hold the first ever hearings about the impact of migraine and other headache disorders on this sizable American population.

The Alliance encourages all of those with migraine and other headache disorders—as well as those who are a family member, are close to them or work with them—to sign the petition. It only takes a minute. Sign the petition here, and thank you for your support.

The Untold Story of Migraine-Related Nausea

2012-01-19T00:00:00-05:00

by Jane Hollingsworth, Founder and CEO

As I mentioned in our inaugural Innovating Neuroscience blog, I am a long-time migraine sufferer. For many years, I had migraines that included visual disturbance, headache pain and debilitating nausea. While the headaches were brutal, most often the nausea was the worst part. I desperately wanted relief but couldn’t stomach the thought of even sipping water. I think most people who have ever experienced severe nausea can relate.

When I was first diagnosed with migraine, however, I didn’t know that nausea was the second most common symptom of a migraine attack. Nor did my physician address it in my treatment or even talk about it. At that time, and far too often even today, all the focus was on the headache.

Today, we know a great deal more about migraine-related nausea (referred to as MRN) and its impact on migraine attacks, treatment and recovery. The facts are powerful. We know that of the 31 million American adults who have migraine, up to 90 percent of them have experienced MRN with an attack. And nearly one out of every two migraine patients is like me, experiencing nausea in half or more of their attacks. (More MRN facts are available here.)

As such, what happens to people like me with MRN is that we often feel the need to wait for the nausea to get better before treating the migraine. In the worst case, we just avoid treatment altogether. This is in spite of research showing that waiting to treat, and certainly going without treatment, increases the severity of the migraine and lengthens the time for recovery. But what choice do we have? If the treatment is oral and we can’t stomach an oral, not much. In fact, any treatment that requires us to put something in our mouth or up our nose violates, as a fellow migraine sufferer put it, the “no-fly zone” for those with MRN.

Research also tells us that patients who have frequent MRN report more medication side effects and more migraine-related interference in work, family, and social life. Those of us with MRN already know this, but it is good to have the research to back us up. We are not whiners! We just need a different way to treat our migraines – a way that takes into account the MRN and the difficulty with the “no-fly zone.”

So, my personal experience AND the research tell us that MRN is a significant factor to be considered for effectively treating migraine. I, and all of us at NuPathe, am on a mission to make sure that MRN is no longer overlooked by those who treat our migraines. We want to improve the patient-physician dialogue and to educate both patients and healthcare providers about the prevalence of MRN, its effect on patients and its impact on treatment. We encourage all patients to talk with their healthcare providers about diagnosis and treatment of migraine, including MRN.

Nearly Half of Migraine Sufferers Experience Nausea Frequently During Migraine Attacks: Survey Links Frequent Nausea to Reduced Migraine Medication Satisfaction and Increased Disability

2012-03-09T00:00:00-05:00

by Suzanne Gagnon, MD, FACP, Vice President and Chief Medical Officer
Data from the largest ever study of migraine sufferers, the American Migraine Prevalence and Prevention Study (AMPP) were presented last summer at the 53rd Annual Scientific Meeting of the American Headache Society (AHS) and are worthy of further discussion. These data show that nearly half of all migraine sufferers experience frequent nausea – defined as experiencing nausea as a symptom of their migraine in at least half of their attacks.

Migraineurs with frequent migraine-related nausea (MRN) reported significant dissatisfaction with medication effectiveness and side effects. They also tend to experience a greater number of migraine symptoms, including pain (that gets worse with activity), photophobia, phonophobia, and lack of appetite.

Frequent MRN was also found to be a substantially debilitating feature of migraine, leading to significantly worse medical outcomes. In addition, frequent MRN was associated with increased medication-related impairment in work, family, and social life. Specifically, the data show an effect on work or school functioning, household work functioning, and family and social activities.

Following analysis of these data, we know a bit more about what high-frequency MRN sufferers are like. Frequent MRN is more common in women and afflicts people of all races and ages. Those with frequent MRN were more likely to be occupationally disabled or on medical leave than those with no or rare MRN.

The fact is that migraine-related nausea can be as debilitating to migraine sufferers as the headache. Some migraineurs say that they can stumble through their day with the headache, but when faced with nausea as well, they are unable to function, often paralyzed by a combination of severe throbbing head pain and gripping nausea.

References

Frequent Nausea in Episodic Migraine (EM) is Common and Associated with Increased Burden: Results from the American Migraine Prevalence and Prevention (AMPP) Study Dawn C. Buse PhD, Michael L. Reed PhD, Kristina M. Fanning PhD, Richard B. Lipton MD American Headache Society, June 2012

Relationship between High-Frequency Nausea and Treatment Satisfaction in Episodic Migraine (EM): Results from the American Migraine Prevalence and Prevention (AMPP) Study Richard B. Lipton MD, Michael L. Reed, PhD, Kristina M. Fanning PhD, Dawn C. Buse PhD, American Headache Society, June 2012

The Burden of Non-Compliance in the Treatment of Schizophrenia

2012-03-28T00:00:00-04:00

By Suzanne Gagnon, MD, FACP, Vice President and Chief Medical Officer

Schizophrenia is a severe chronic disease with very costly consequences of medication non-compliance, both economically and socially.

Chronic schizophrenia is a life-long, serious psychiatric illness that causes people to lose touch with reality. It interferes with the ability to think clearly, manage emotions, make decisions and relate to others. The disease afflicts 24 million people worldwide. Onset of schizophrenia typically occurs in young adults, between 15 and 35 years old. For females, the incidence of schizophrenia generally peaks approximately five years later than in males.

Unfortunately, non-compliance with medication is high for schizophrenia patients. This lack of compliance is one of the most common causes of relapse and leads to dire consequences for patients, their families and the healthcare system. Studies show that, in general, compliance with medication for schizophrenia patients ranges from 45 to 65 percent. In one study 74 percent of schizophrenia patients became non-compliant with their medication within 18 months of beginning treatment.

Because of the nature and severity of the disease, relapse in schizophrenia patients can be far more serious than for other diseases. Moreover, research tells us that when the relapse is due to non-compliance, it is often more severe and is associated with higher rates of violence and suicide than relapse due to other causes.

As of 2002, the estimated direct healthcare costs of schizophrenia in the U.S. were $22.7 billion. These include acute and chronic patient care, medication and long-term care. Even more concerning, however, is that the indirect costs are nearly double those of direct healthcare costs. Indirect costs include lost income for both patient and caregiver, use of homeless shelters, law enforcement, and premature mortality (typically suicide).

Longer acting formulations of antipsychotics should result in better patient adherence to treatment regimens. They would require less daily maintenance by the patients and caregivers, a very important advantage for this patient population, and, ideally, would also be more tolerable to patients because of delivering a more stable dose over a longer period of time. Decreasing medication noncompliance in schizophrenia with the intention of preventing patient relapse would have a significant impact both medically and economically, not only to those patients who suffer chronically, but to their caregivers, their families and society in general.

References

World Health Organization quick facts.

NuPathe analysis; Decision Resources (2004); US Census Bureau IDB.

Eaton, W. Johns Hopkins Bloomberg School of Public Health (2006).

Thieda et al. Psychiatric Services (2003).

The Clinical Antipsychotic Trials in Intervention Effectiveness, or CATIE, study, conducted between 2001 and 2004.

Prior, T. Avoiding Relapse in Schizophrenia: Non-Compliance and the Use of Long-Acting Injectables.

Wu et al. Journal of Clinical Psychiatry (2005).

Mothering with Migraine

2012-05-08T00:00:00-04:00

by Jane Hollingsworth, CEO

With the approach of Mother’s Day, my blog today focuses on the millions of mothers who suffer from migraine and the impact that this disease has on families.

Migraine is more common than many may realize. It afflicts more people than other common chronic illnesses such as diabetes, hypertension and asthma and doesn’t target the elderly, as many other diseases do. It primarily hits those of us in the workforce and/or raising a family, and it hits us hard – with nearly one of four families affected by migraine and women three times more likely to suffer from migraine than men.

Research tells us that the burden of migraine is broad, straining relationships, family life, and the ability to participate in social engagements. Nearly half of migraine patients report interference with social activities, and nearly 60% report significant impact on relationships with family members. Clearly, migraine interrupts life: half of patients report severe impairment in activities or the need for bed rest. Chores and errands go undone, family social activities are missed, and plans are avoided for fear of cancellation due to migraine.

The burden of migraine affects family relationships deeply. Half of all migraine patients believe that because of their migraine, they were more likely to argue with their partners and children. Nearly as many thought they would be better parents were it not for their migraine headaches. Some children even missed or were late to school due to a parents’ migraine.

As a migraine sufferer too, I can relate. Over the years, my migraines have caused me to miss school events, my children’s activities, social functions and plenty of work. I could not always be there to take care of my children because the headache pain and debilitating migraine-related nausea forced me to bed and a dark room. Needless to say, it’s a tough thing to explain to small children that their mother is down for the count…again! On the other hand, it did make them more self-sufficient and, as they grew up, helped hone their cooking skills. As all mothers know, however, I would have preferred it otherwise.

Today, I am in the lucky position of leading a company that is developing innovative treatments for migraine patients and others with neurologic and psychiatric diseases. As a migraine sufferer, I decided I had to do something about the helpless feeling we all get with migraines and have built a company to do that. I am proud to represent both the patient and the treatment provider, and both drive my determination. For all the mothers in world who suffer from migraine, please know that we are working for you and we hope to deliver a valuable new treatment in the near future.

Happy Mother’s Day.

References

Lipton RB et al. The family impact of migraine: population-based studies in the USA and UK, Cephalalgia, 2003.

Lipton RB et al. Prevalence and Burden of Migraine in the United States: Date from the American Migraine Study II, Headache, 2001.

Buse et al. Data presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011.

The Economic Burden of Migraine

2012-06-14T00:00:00-04:00

by Jane Hollingsworth, Founder and CEO

In my last blog post, I discussed the significant social and family burden of migraine. For all of us sufferers and non-sufferers alike, the economic burden resulting from the 31 million adults in the US with migraine is also quite substantial and may even surprise you.

Let’s start with the big picture. The overall cost of migraine in the U.S. is more than $14 billion annually.

Migraine patients use more healthcare than those without migraine, and they visit general practitioners, specialists, psychiatrists and emergency rooms more often. They have almost double the medical claims and 2½ times the pharmacy claims than those who don’t suffer from migraine. One study showed that migraine patients had an average of $7,007 in medical claims in a year compared with $4,436 for non-migraine patients—a difference of $2,571 per patient.

For those who suffer from migraine-related nausea (MRN) along with their headache pain, the costs are even higher. If you’ve followed my other posts about MRN, you already know that up to 90 percent of migraine patients have experienced MRN, and half experience MRN in half or more of their migraine attacks. The impact on this huge group of patients is significant: they visit specialists twice as often, visit emergency rooms and urgent care facilities five times more often and have eight times higher overnight hospital stay costs than those without MRN.

Indirect costs of migraine are high too. There are many days when a migraine patient simply cannot go to work or is not working at full capacity. All told, U.S. employers lose $13 billion a year due to missed worked and reduced productivity of migraine patients. In fact, women who suffer from migraine miss an average of eight workdays from absenteeism and reduced work productivity each year. One very large employer with more than 87,000 employees lost 538 person-years of work annually, translating to a whopping $23.8 million in lost employee output. All in all, it’s a hefty price tag for employers.

So what can be done to reduce the staggering costs of migraine? Effective treatment—resulting in improved outcomes—is obviously the key. Research supports that care tailored to an individual’s specific symptoms and severity is best. By understanding the severity or disability of the headache pain, nausea, and other symptoms, physicians can choose the most appropriate treatment. I believe choice of treatment, especially for those suffering from MRN, is very important. Stratified care improves the patient outcomes, which in turn reduces return office visits and allows migraine patients to return to work and normal productivity levels.

We are committed to working toward FDA approval of our migraine patch and making a new non-oral treatment available to patients.

References

Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med. 1999;159:813-18.

Edmeads J, Mackell JA. The economic impact of migraine: an analysis of direct and indirect costs. Headache. 2002;42:501-09.

Clouse JC, Osterhaus JT. “Healthcare resource use and costs associated with migraine in a managed healthcare setting.” Annals of Pharmacotherapy. 1994;28: 659-64.

Hawkins K, Wang S, Rupnow M. “Direct Cost Burden Among Insured US Employees With Migraine.” Headache. 2008;48:553-563.

Schwartz BS , Stewart WF , Lipton RB. “Lost workdays and decreased work effectiveness associated with headache in the workplace.” Journal of Occupational and Environmental Medicine. 1997;39:320–327.

Gerth WC et al. “Productivity Cost Benefit to Employers of Treating Migraine With Rizatriptan: A Specific Worksite Analysis and Model.” Journal of Occupational and Environmental Medicine. 2004: 46.

Brixner, DI, and Brandes, JL, “Migraine Matters: The Role of Triptans in Relieving the Burden in Managed Care.” Supplement to Journal of Managed Care Pharmacy. 2004;10:S2-S16.