With new science comes new hope for migraine patients

Those living with migraine know all too well how this invisible disease can impact one’s life. People with migraine experience attacks that can be severely burdensome, intensely painful and debilitating.^1-3 A migraine attack is more than just a headache — the pain during a migraine attack is often described as an intense throbbing or pulsing pain in one area of the head with symptoms ranging from aura, nausea, and sensitivity to light and sound.⁴

The impact of migraine

In addition to having to push through the challenges of living with the disease, many people with migraine must also deal with the undeniable burden it imposes on their personal and professional lives. Migraine also has an enormous societal impact — the estimated total direct medical cost for U.S. adults with migraine is up to $56 billion a year, according to the Medical Expenditures Panel Survey.⁵

The World Health Organization considers a day lived with severe continuous migraine to be as debilitating as a day lived with dementia or acute psychosis and more disabling than blindness or paraplegia.^6,7 So why is it that a disease that affects more than 30 million adults in the U.S. remains underdiagnosed and undertreated?^8-11

The need for additional treatment options

There hasn’t been a new class of acute treatment approved for migraine in over two decades. Triptans are recommended as an acute therapy for migraine for appropriate patients by the American Headache Society.¹² However, 79% of patients in a survey of 183 patients from 3 centers said they are willing to try another acute treatment.¹³ In addition, a survey of patients with migraine have shown that 87% of patients prioritize fast and complete elimination of pain from acute treatment options.¹⁴ Understanding a patient’s expectations of acute treatments for migraine may help improve chances for successful migraine management.¹⁴

A new era for the acute treatment of migraine

Fortunately, we are entering a new era for the acute treatment of migraine. In 2018, the FDA raised the clinical trial bar and issued guidance that recommends clinical trials for acute treatment of migraine demonstrate complete elimination of pain and most bothersome symptom at two hours rather than just pain relief.¹⁵ The American Headache Society issued similar guidance last year in which it notes rapid and consistent freedom from pain as a goal of acute migraine treatment.¹² Lilly is dedicated to discovering treatments for migraine and other disabling headache disorders and helping the people affected by these serious neurologic diseases.

REYVOW^TM (lasmiditan) C-V, 50 mg and 100 mg tablets, Lilly’s new oral medication for the acute treatment of migraine, with or without aura in adults, gives patients the chance for rapid and complete elimination of migraine in two hours after a single dose, along with a patient’s most bothersome symptom of sensitivity to light, sensitivity to sound, or nausea, see data in Fact Sheet above.¹⁶ With new science comes new hope. Complete elimination of pain should be the primary goal of acute treatment for migraine and we encourage patients and doctors to think of freedom from migraine pain and related symptoms as an expectation for their treatment.

Learn more at www.reyvow.com.

INDICATION AND USAGE
REYVOW is a serotonin (5-HT) 1F receptor agonist (ditan) indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use: REYVOW is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION FOR REYVOW
WARNINGS AND PRECAUTIONS
Driving Impairment 
REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects’ ability to drive. Additionally, more sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW.

Central Nervous System Depression
REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants. Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken.

Serotonin Syndrome
In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who were not taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOW during coadministration with serotonergic drugs. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular signs, and/or gastrointestinal signs and symptoms. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue REYVOW if serotonin syndrome is suspected.

Medication Overuse Headache
Overuse of acute migraine drugs may lead to exacerbation of headache. Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

ADVERSE REACTIONS
The most common adverse reactions associated with REYVOW (≥2% and greater than placebo in clinical studies) were dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness.

DRUG ABUSE AND DEPENDENCE
REYVOW contains lasmiditan, a Schedule V controlled substance.

Abuse
In a human abuse potential study in recreational poly-drug users (n=58), single oral therapeutic doses (100 mg and 200 mg) and a supratherapeutic dose (400 mg) of REYVOW were associated with statistically significantly higher “drug liking” scores than placebo, indicating that REYVOW has abuse potential. At all doses, REYVOW was associated with statistically significantly lower “drug liking” scores than alprazolam. Euphoric mood occurred to a similar extent with REYVOW 200 mg, REYVOW 400 mg, and alprazolam 2 mg (43-49%). A feeling of relaxation was noted in more subjects on alprazolam (22.6%) than with any dose of REYVOW (7-11%). Phase 2 and 3 studies indicate that, at therapeutic doses, REYVOW produced adverse events of euphoria and hallucinations to a greater extent than placebo. However, these events occur at a low frequency (about 1% of patients). Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.

Dependence
Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan 200 mg or 400 mg.

See accompanying Prescribing Information and Medication Guide.

LM HCP ISI 11JAN2020

¹ Payne KA, Varon SF, Kawata AK, et al. The International Burden of Migraine Study (IBMS): Study design, methodology, and baseline cohort characteristics. Cephalalgia. 2011;31:1116-1130.
² Stewart WF, Lipton RB. The economic and social impact of migraine. Eur Neurol. 1994;34(suppl 2):12-17.
³ Brandes JL. Global trends in migraine care: results from the MAZE survey. CNS Drugs. 2002;16(suppl 1):13-18
⁴ Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
⁵ Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013. J Pain. 2017;18(1):96-107.
⁶ Harwood RH, Sayer AA, Hirschfeld M. Current and future worldwide prevalence of dependency, its relationship to total population, and dependency rations. Bull World Health Organ. 2004;82:251-258.
⁷ Menken M, Munsat TL, Tooole JF. The global burden of disease study: implications for neurology. Arch Neurol. 2000;57:418-420.
⁸ Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; on behalf of the AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
⁹ Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0001.
¹⁰ US Census Bureau. Quick Facts. http://www.census/gov/quickfacts/fact/table/US/PST045218. Updated July 1, 2018. Accessed May 31, 2019.
¹¹ Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention Study. Headache. 2007;47:355-363.
 ¹² American Headache Society. The American Headache Society Position Statement on Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019;59:1-18.
¹³ Bigal M, Rapoport A, Aurora S, et al. Satisfaction with current migraine therapy: experience from 3 centers in US and Sweden. Headache. 2007;47:475-479.
¹⁴ Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39[suppl 2]:S20-S26.
¹⁵ U.S. Food and Drug Administration. Migraine: developing drugs for acute treatment guidance for industry. Center for Drug Evaluation and Research. 2018;1-9.
¹⁶ REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC, 2020.
¹⁷ Krege JH, Rizzoli PB, Liffick E, et al. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN. Cephalalgia. 2019;39:957-966.

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