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Clinical Study Design: CENTURION

REYVOW (lasmiditan) was evaluated in CENTURION, a multiple attack consistency study. In the study, consistency was defined as achieving pain freedom in 2 out of the first 3 treated attacks.¹

In CENTURION, patients (N=1471; REYVOW: 971, Placebo: 500) were required to be age 18 and older, have a history of migraine for at least 1 year, have 3-8 migraine attacks/month, and have at least moderate migraine disability (MIDAS score ≥11)¹

PAIN FREEDOM¹

Complete elimination of moderate to severe headache pain at 2 hours during the first treated attack

PAIN FREEDOM ACROSS MULTIPLE ATTACKS¹

Complete elimination of moderate to severe headache pain at 2 hours in 2 out of the first 3 treated attacks

Patients were instructed to take the study drug to treat 4 attacks within 4 hours of headache onset when the pain was moderate to severe¹

Doses evaluated: 100 mg, 200 mg ¹

SELECT IMPORTANT SAFETY INFORMATION

Medication Overuse Headache
Overuse of acute migraine drugs may lead to exacerbation of headache (i.e., medication overuse 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.

For the acute treatment of migraine with or without aura in adults²

REYVOW CAN DELIVER FAST MIGRAINE PAIN RELIEF IN 60 MINUTES WITH A SINGLE DOSE³

Pain relief, a secondary endpoint, was defined as reduction of migraine pain from moderate or severe to mild or none at 2 hours post-dose during the first attack.

67% of patients taking REYVOW 200mg, 65% taking 100mg REYVOW, and 43% taking placebo achieved pain relief at 2 hours. 51% of patients taking REYVOW 200mg, 48% taking REYVOW 100mg, and 31% taking placebo achieved pain relief at 1 hour. — The percentage of patients who experienced migraine pain relief at 2 hours and 1 hour with REYVOW vs placebo in the CENTURION study.

In the CENTURION study, 420 patients took 200 mg of REYVOW, 393 patients took 100 mg of REYVOW, and 420 patients took placebo. At 1 hour, 48% of patients experienced pain relief when taking 200 mg of REYVOW, 51% of patients experienced pain relief when taking 100 mg of REYVOW, and 31% of patients experienced pain relief when taking placebo. At 1 hour, there was a 17% difference in patients who experienced pain relief when taking 200 mg of REYVOW vs placebo (P<.001 vs placebo) and a 20% difference in patients who experienced pain relief when taking 100 mg of REYVOW vs placebo (P<.001 vs placebo). At 2 hours, 65% of patients experienced pain relief when taking 200 mg of REYVOW, 67% of patients experienced pain relief when taking 100 mg of REYVOW, and 43% of patients experienced pain relief when taking placebo. At 2 hours, there was a 22% difference in patients who experienced pain relief when taking 200 mg of REYVOW vs placebo (P<.001 vs placebo) and a 24% difference in patients who experienced pain relief taking 100 mg of REYVOW vs placebo (P<.001 vs placebo).

Results for pain relief at 30 minutes are descriptive and not controlled for Type 1 error.

See pain relief data for pivotal trials SPARTAN/SAMURAI

See CENTURION study design

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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.

For the acute treatment of migraine with or without aura in adults²

PATIENTS ACHIEVED MIGRAINE PAIN FREEDOM AT 2 HOURS WITH A SINGLE DOSE OF REYVOW⁴

Some patients achieved pain freedom as early as 1 hour (200 mg)⁴

28% of patients taking REYVOW 200mg, 25% taking 100mg REYVOW, and 8% taking placebo achieved pain freedom at 2 hours. 12% of patients taking REYVOW 200mg and 2% taking placebo achieved pain freedom at 1 hour. — The percentage of patients who achieved migraine pain freedom at 2 hours with REYVOW vs placebo in the CENTURION study.

In the CENTURION study, 420 patients took 200 mg of REYVOW, 393 patients took 100 mg of REYVOW, and 420 patients took placebo. At 1 hour, 12% of patients achieved pain freedom when taking 200 mg of REYVOW and 2% of patients achieved pain freedom when taking placebo. At 1 hour, there was a 10% difference in patients taking 200 mg of REYVOW vs placebo. At 2 hours, 28% of patients achieved pain freedom when taking 200 mg of REYVOW, 25% of patients achieved pain freedom when taking 100 mg of REYVOW, and 8% of patients achieved pain freedom when taking placebo. At 2 hours, there was a 20% difference in patients taking 200 mg of REYVOW vs placebo and a 17% difference in patients taking 100 mg of REYVOW vs placebo.

Results for pain freedom at 1 hour for 100 mg and less than 1 hour for all doses are descriptive and not controlled for Type 1 error. Effect of pain freedom at these time points cannot be regarded as statistically significant.

See pain freedom data for pivotal trials SPARTAN/SAMURAI

See CENTURION study design

SELECT IMPORTANT SAFETY INFORMATION

Abuse
REYVOW contains lasmiditan, a Schedule V controlled substance (C-V). REYVOW has abuse potential. Evaluate patients for risk of drug abuse and observe them for signs of REYVOW misuse or abuse.

For the acute treatment of migraine with or without aura in adults²

REYVOW EFFICACY WAS CONSISTENT OVER MULTIPLE ATTACKS⁵

Patients who achieved complete elimination of pain at 2 hours reported similar effects in 2 out of 3 attacks when treated with REYVOW⁵

23% of patients taking REYVOW 200mg, 14% taking 100mg REYVOW, and 4% taking placebo achieved pain freedom at 2 hours in at least 2 out of 3 treated migraine attacks. — Results of the CENTURION study, showing the percentage of patients who achieved migraine pain freedom at 2 hours in at least 2 out of 3 treated migraine attacks with REYVOW vs placebo.

In the CENTURION study, 318 patients took 200 mg of REYVOW, 323 patients took 100 mg of REYVOW, and 348 patients took placebo. At 2 hours, 23% (P<.001 vs placebo) of patients taking 200 mg achieved pain freedom and 14% (P<.001 vs placebo) of patients taking 100 mg achieved pain freedom while 4% of patients taking placebo achieved pain freedom. There was a 19% difference in the percentage of patients taking 200 mg vs placebo and a 10% difference in the percentage of patients taking 100 mg vs placebo.

See CENTURION study design

SELECT IMPORTANT SAFETY INFORMATION

Driving Impairment
REYVOW may cause significant driving impairment. 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.

For the acute treatment of migraine with or without aura in adults²

REYVOW MAY PROVIDE PAIN FREEDOM AT 2 HOURS IN PATIENTS WITH AN INSUFFICIENT RESPONSE TO 1 OR MORE TRIPTAN THERAPY OR UNABLE TO TAKE TRIPTANS⁶

CENTURION data chart for percentage of patients who achieved migraine pain freedom with Reyvow vs placebo — The percentage of patients who are unable to take triptans or have had an insufficient response to 1 or more triptans who achieved migraine pain freedom with REYVOW vs placebo during the first of 3 migraine attacks in the CENTURION study.

In the CENTURION study, 198 patients took 200 mg of REYVOW, 169 patients took 100 mg of REYVOW, and 182 patients took placebo. At 2 hours, 25% of patients achieved pain freedom when taking 200 mg of REYVOW (P<.001 vs placebo), 22% of patients achieved pain freedom when taking 100 mg of REYVOW (P<.001 vs placebo), and 8% of patients achieved pain freedom when taking placebo. At 2 hours, there was a 17% difference in patients taking 200 mg of REYVOW and placebo and a 14% difference in patients taking 100 mg of REYVOW and placebo.

^†The analysis of pain freedom at time points earlier than 2 hours were considered exploratory and have not been controlled for Type 1 error. No conclusions of statistical significance can be drawn.

Insufficient response is defined as those patients who:

Never achieved pain freedom at 2 hours or did not achieve pain freedom in 2 out of 3 attacks with their most recent triptan
Discontinued a triptan due to lack of efficacy, tolerability, or contraindications
Or current triptan users who had a Migraine Treatment Optimization Questionnaire, 4-item version (mTOQ-4)^‡ score of poor or very poor response at baseline

^‡Migraine Treatment Optimization Questionnaire is a validated, self- administered questionnaire that assesses the efficacy of acute migraine treatment. This study uses the 4-item version.

See CENTURION study design

Learn about safety information for REYVOW

SEE SAFETY DATA

References:

Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0026.
REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0029.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0028.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0027.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0032.

IMPORTANT SAFETY INFORMATION

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 e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). 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 (e.g., ergotamines, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (i.e., medication overuse 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.

ABUSE

REYVOW contains lasmiditan, a Schedule V controlled substance (C-V).
REYVOW has abuse potential. Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.

See Prescribing Information and Medication Guide.
LM HCP ISI 28SEP2020

INDICATIONS

REYVOW is 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.

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Collapse accordion Clinical Trial Design

Clinical Study Design: CENTURION

Collapse accordion Pain Relief

REYVOW CAN DELIVER FAST MIGRAINE PAIN RELIEF IN 60 MINUTES WITH A SINGLE DOSE3

Collapse accordion Pain Freedom in a Single Attack

PATIENTS ACHIEVED MIGRAINE PAIN FREEDOM AT 2 HOURS WITH A SINGLE DOSE OF REYVOW4

Collapse accordion Pain Freedom in Multiple Attacks

REYVOW EFFICACY WAS CONSISTENT OVER MULTIPLE ATTACKS5

Collapse accordion Triptan Insufficient Responders

REYVOW MAY PROVIDE PAIN FREEDOM AT 2 HOURS IN PATIENTS WITH AN INSUFFICIENT RESPONSE TO 1 OR MORE TRIPTAN THERAPY OR UNABLE TO TAKE TRIPTANS6

Learn about safety information for REYVOW

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

ABUSE

INDICATIONS

REYVOW CAN DELIVER FAST MIGRAINE PAIN RELIEF IN 60 MINUTES WITH A SINGLE DOSE³

PATIENTS ACHIEVED MIGRAINE PAIN FREEDOM AT 2 HOURS WITH A SINGLE DOSE OF REYVOW⁴

REYVOW EFFICACY WAS CONSISTENT OVER MULTIPLE ATTACKS⁵

REYVOW MAY PROVIDE PAIN FREEDOM AT 2 HOURS IN PATIENTS WITH AN INSUFFICIENT RESPONSE TO 1 OR MORE TRIPTAN THERAPY OR UNABLE TO TAKE TRIPTANS⁶