FDA Approves First Drug for Both Migraine Treatment and Prevention

By Pat Anson, PNN Editor

Migraine sufferers have a new medication that not only treats migraines, but can also be used to help prevent them. Biohaven Pharmaceuticals announced this week that Nurtec (rimegepant) -- a drug already being used to treat migraine pain – has been approved by the FDA as a migraine preventative, making it the first migraine medication that can be used for both treatment and prevention.

Nurtec is a calcitonin gene-related peptide (CGRP) inhibitor, a relatively new class of medication that blocks a protein released during migraine attacks from binding to nerve receptors in the brain. Since 2018, the FDA has approved a handful of CGRP medications, most which are taken by injection.

Nurtec is a quick-dissolving tablet that is taken orally. A single dose can treat migraine pain for up to 48 hours. The expanded FDA approval means Nurtec can now also be taken daily or every other day to help reduce the frequency of migraines. 

“The FDA approval of Nurtec ODT for the preventive treatment of migraine -- along with its acute treatment indication -- is one of the most groundbreaking things to happen to migraine treatment in my 40 years of practicing headache medicine. To have one medication patients can use to treat and prevent migraine will likely change the treatment paradigm for many of the millions of people who live with migraine," said Peter Goadsby, MD, a Professor of Neurology at the University of California, Los Angeles.

Goadsby was one of the investigators in a Phase 3 study that helped prove Nurtec can be used as a migraine preventive. In findings recently published in The Lancet, Nurtec reduced the number of migraine days per month by 30% after one week of treatment. After three months of treatment, about half of the patients taking Nurtec had at least a 50% reduction in the number of moderate-to-severe migraine days per month.

Nurtec was well-tolerated by most patients during the clinical trial. Some reported nausea, stomach pain and indigestion.

"This FDA approval marks the beginning of a new era for migraine treatments, allowing the potential for healthcare professionals to prescribe, and patients to have, a single medication to treat and prevent migraine attacks,” Biohaven CEO Vlad Coric, MD, said in a statement. “This groundbreaking approach to treating the full spectrum of migraine disease, from acute therapy to prevention, can have a significant impact in a patient's life by helping to decrease treatment plan complexity and reduce challenges with adherence and polypharmacy.”

One obstacle to using Nurtec is its cost. Currently, a single 75mg tablet is priced at about $117. A supply of eight tablets is around $941, depending on your insurance coverage and pharmacy.  Biohaven has a patient assistance program that can help some patients who lack insurance or can’t afford the drug.

A recent survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication. About 11 percent said they were using a CGRP to treat migraine pain. Patients who did not try the drugs said they were concerned about side effects, long-term safety and their cost.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

A Pained Life: We Need More Than Opioids

By Carol Levy, PNN Columnist

There is no question we need to be active and stay on top of what the CDC and other federal agencies are doing that impedes our ability to get opioid medication.  For many chronic pain patients, opioids are the only effective pain reliever.

I wonder though: In focusing almost all of our energies on the issue of opioids, are we ignoring another front that needs to be addressed?

Cancer seems like the best analogy to me, maybe the only one. There are many forms of cancer but at the end of the day they all involve the excessive growth of cells that spread into surrounding tissue. All cancers, to my knowledge, start from that one errant misfire.

In recent years we have seen cancer treatments change and become more specific -- this combination of chemotherapy for lung cancer, a different type of chemo for sarcoma or leukemia, and so on. But ultimately, they are all some form of chemotherapy.

Unlike cancer, we can’t put all of our eggs into one basket. There is no universal type of “chronic pain.” We need to have different treatments and regimens for each pain disorder.

Trigeminal neuralgia and other cranial neuropathies have a different cause and mechanism than rheumatoid arthritis and other autoimmune diseases. So do multiple sclerosis and arachnoiditis.  Conditions like fibromyalgia and Chronic Regional Pain Syndrome (CRPS) are still poorly understood and difficult to treat.

Unlike cancer, we need to have multiple approaches to chronic pain syndromes. No one has come up with anything better than opioids for pain control and relief – at least not yet -- so this choice must remain accessible. But we must also not lose sight of the need for better treatments and possibly even cures for every pain condition.

We have to let it be known that we need opioids, not because they make us high, but because there is nothing else out there to take their place.  It is well past time for the government to understand, if they want to end the use of opioids, they must first ensure that there are other viable options out there.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Lessons About the Opioid Crisis from ‘Unbroken Brain’

By Roger Chriss, Columnist

The book “Unbroken Brain: A Revolutionary New Way of Understanding Addiction” by Maia Szalavitz offers invaluable insights about addiction. Her key point is that addiction should be seen as a learning disorder -- not a moral failing or brain disease.

Szalavitz says addiction treatment and drug policy should meet addicts where they are and deal with their reality, instead of using the moralistic or legalistic framework commonly seen in the opioid crisis.

Throughout the book, Szalavitz shares her own experiences with drug use in a way that does not mythologize addiction or recovery. Instead, her personal history highlights that there is no such thing as a typical addict and that addiction is not simply a moral failing or choice.

Szalavitz explains that addiction results from a complex combination of a person’s genetic makeup, early life experiences, and socio-cultural situation. Specifically, she states that: "There are three critical elements to it; the behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

She likens addiction to dysfunctional self-medication, an effort to self-soothe and regulate internal states that have gone horribly wrong. This means that addiction is not about a substance, but about a person.

“Drugs alone do not ‘hijack the brain.’ Instead, what matters is what people learn -- both before and after trying them,” Szalavitz writes. “Addiction is, first and foremost, a relationship between a person and a substance, not an inevitable pharmacological reaction.”

Further, she states that “by itself, nothing is addictive; drugs can only be addictive in the context of set, setting, dose, dosing pattern, and numerous other personal, biological, and cultural variables.”

And there are several major risk factors for addiction, including severe early childhood trauma or abuse, existing mental illness, and serious life challenges. Particular emphasis is given to a history of abuse.

“In fact, one third to one half of heroin injectors have experienced sexual abuse, with the usual abuse rates for women who inject roughly double those for men. And in 50% of these sexual abuse cases, the offense was not just a single incident but an ongoing series of attacks, typically conducted by a relative or family friend who should have been a source of support, not stress,” wrote Szalavitz.

She also states that addiction is not just about euphoria: “Research now suggests that there are at least two distinct varieties of pleasure, which are chemically and psychologically quite different in terms of those effects on motivation. These types were originally characterized by psychiatrist Donald Klein as the ‘pleasure of the hunt’ and the ‘pleasure of the feast’.”

This means that addiction is about far more than just dopamine levels: “If dopamine is what creates the sense of pleasure, animals shouldn’t be able to enjoy food without it. Yet they do.”

Lower Risk of Addiction to Opioid Medication

On the subject of opioid medication, Szalavitz notes that about one in seven people do not tolerate opioids well enough to take them repeatedly and therefore have essentially no risk of opioid use disorder. Because of this and the importance of “set and setting” to addiction, she explains, “medical use of drugs carries a far lower risk of addiction than recreational use does.”

Because addiction involves a person in a particular sociocultural situation, she writes that “People with decent jobs, strong relationships, and good mental health rarely give that all up for intoxicating drugs; instead, drugs are powerful primarily when the rest of your life is broken.”

Approaches to addiction treatment that don't recognize the above are unlikely to succeed. Detox regimens, short-term medication therapy, and abstinence-only programs like Alcoholics Anonymous are generally inadequate. For instance, Szalavitz found a 2006 Cochrane Review that summarized the data plainly: “No experimental studies unequivocally demonstrated the effectiveness of AA.”

Instead, Szalavitz emphasizes the value of harm reduction, a process whose aim is to "meet the addicts where they are" and support them unconditionally, even if this means clean needle exchanges and safe injection sites.

“Don’t focus on whether getting high is morally or socially acceptable; recognize that people always have and probably always will take drugs and this doesn’t make them irrational or subhuman,” she wrote.

But American policy toward illegal drugs and attitudes toward medications with psychotropic effects are grounded in a moralistic view. “More generally, in the West, unearned pleasure has been labeled as sinful—the opposite of valued,” Szalavitz writes, explaining why any medication that helps a person feel good, or just not feel as bad, is viewed negatively. This has led to all manner of misguided policy in the War on Drugs.

“One of the sad ironies of our current drug policy is that the same treatment providers who have been cheerleaders for the war on drugs and who advocate the ongoing criminalization of drug use also claim to want to destigmatize ‘the disease of addiction’,” she wrote.

“This approach is doomed to failure because “punishment cannot solve a problem defined by its resistance to punishment.” Moreover, it is cruelly counterproductive because “the uniquely moral nature of the way we treat addicts as both sick and criminal also reinforces stigma.” By contrast, understanding addiction as a learning disorder leads to harm reduction as the core of a more effective approach to treatment.

“Unbroken Brain” is not pedantic or moralistic. Indeed, Szalavitz says that part of the reason U.S. policy toward drug addiction has failed is that it is pedantic and moralistic. But she also says that people who now say that addiction is a "brain disease" are missing the point too. "Drug exposure alone doesn't cause addiction," she says in the conclusion of the book.

A person's situation and circumstances matter a lot in drug use and addiction. And treatment requires recognizing that even the most addicted person can still learn and make positive changes in their life when given the chance.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.