EXPLORE WHAT'S POSSIBLE WITH REYVOW¹

REYVOW (lasmiditan), an acute treatment for migraine, was approved by the FDA using 2018 guidance for clinical trial efficacy endpoints to align with what patients prioritize from an acute treatment.^1-3

Clinical Study Design: SAMURAI AND SPARTAN

REYVOW is a tablet that was evaluated in 2 randomized, double-blind, placebo-controlled, single-attack trials^1,4,5

4439 patients age 18 and older were dosed (REYVOW=3177; placebo=1262), including those with:
- ≥2 cardiovascular risk factors (41%)⁶
- Concomitant use of migraine preventive drugs (22%)¹
- Concomitant use of serotonergic medication (22%)⁷
- Prior triptan exposure within the past 3 months (37%)⁸
All patients had:
- History of migraine for at least 1 year^4,5
- 3-8 migraine attacks/month^4,5
- MIDAS^* score ≥11 (pooled median was 25)⁹
Patients were instructed to take the study drug within 4 hours of headache onset when the pain was moderate to severe¹
Patients were allowed to take a rescue medication 2 hours after taking study drug: however, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of study drug administration¹
Dosing: 100 mg, 200 mg (SAMURAI); 50 mg, 100 mg, 200 mg (SPARTAN)¹

^*Migraine Disability Assessment.

2018 FDA guidance recommends both pain freedom and MBS freedom be efficacy endpoints for FDA approval of new acute treatments for migraine to align with what patients prioritize from an acute treatment.²

PAIN FREEDOM¹

Complete elimination of moderate or severe headache pain at 2 hours

FREEDOM FROM MOST BOTHERSOME SYMPTOM (MBS)¹

Complete elimination of the self-identified most bothersome migraine-associated symptom of photophobia, phonophobia, or nausea (if present at the time of treatment) at 2 hours

Additional Efficacy Endpoint:

PAIN RELIEF¹

Reduction in migraine pain from moderate or severe to mild or none at 2 hours.
The analysis of pain relief was descriptive and was not controlled for Type I error.

SELECT IMPORTANT SAFETY INFORMATION

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 adults¹

EFFECT OF REYVOW ON PAIN RELIEF^1,10

Results from 2 studies, % of patients who experienced pain relief at 2 hours with REYVOW vs placebo — Results from the SAMURAI and SPARTAN studies representing the percentage of patients who experienced pain relief at 2 hours with REYVOW vs placebo.

In the SAMURAI study, 503 patients took 200 mg of REYVOW, 498 patients took 100 mg of REYVOW, and 515 patients took placebo. At 2 hours, 55% of patients experienced pain relief when taking 200 mg, 54% of patients experienced pain relief when taking 100 mg, and 40% of patients experienced pain relief when taking placebo. There was a 15% difference in the percentage of patients taking 200 mg vs placebo and a 14% difference in the percentage of patients taking 100 mg vs placebo.

In the SPARTAN study, 521 patients took 200 mg of REYVOW, 523 patients took 100 mg of REYVOW, 544 patients took 50 mg of REYVOW, and 534 patients took placebo. At 2 hours, 61% of patients experienced pain relief when taking 200 mg, 61% of patients experienced pain relief when taking 100 mg, 56% of patients experienced pain relief when taking 50 mg, and 45% of patients experienced pain relief when taking placebo. There was a 16% difference in the percentage of patients taking 200 mg vs placebo, a 16% difference in the percentage of patients taking 100 mg vs placebo, and an 11% difference in the percentage of patients taking 50 mg vs placebo.

Pain relief at 2 hours, defined as a reduction in pain from moderate or severe to mild or none, was evaluated. The results for pain relief are descriptive and the analysis was not controlled for Type Ι error. Effect of REYVOW on pain relief cannot be regarded as statistically significant.

View Clinical 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.

PAIN RELIEF IS NOT THE SAME AS PAIN FREEDOM

Pain relief means your patients have less pain. Pain freedom means your patients have no pain at all at 2 hours¹.

Pain relief is less pain; pain freedom is zero pain

For the acute treatment of migraine with or without aura in adults¹

PAIN FREEDOM IS POWERFUL. REYVOW CAN HELP YOUR PATIENTS ACHIEVE IT AT 2 HOURS^1,11

Up to 39% of patients achieved complete elimination of migraine pain at 2 hours with a single dose, and some patients achieved pain freedom before 2 hours^1,11

Click to scroll through complete data.

Image 1: Pain Freedom at 2 Hours

Results of the SAMURAI and SPARTAN studies, showing the percentage of patients who achieved migraine pain freedom at 2 hours with REYVOW vs placebo.

In the SAMURAI study, 503 patients took 200 mg of REYVOW, 498 patients took 100 mg of REYVOW, and 515 patients took placebo. At 2 hours, 32% (P<.001 vs placebo) of patients achieved pain freedom when taking 200 mg, 28% (P<.001 vs placebo) of patients achieved pain freedom when taking 100 mg, and 15% of patients achieved pain freedom when taking placebo. There was a 17% difference in the percentage of patients taking 200 mg vs placebo and a 13% difference in the percentage of patients taking 100 mg vs placebo.

In the SPARTAN study, 521 patients took 200 mg of REYVOW, 523 patients took 100 mg of REYVOW, 544 patients took 50 mg of REYVOW, and 534 patients took placebo. At 2 hours, 39% (P<.001 vs placebo) of patients achieved pain freedom when taking 200 mg, 31% (P<.001 vs placebo) of patients achieved pain freedom when taking 100 mg, 28% (P=.006 vs placebo) of patients achieved pain freedom when taking 50 mg, and 21% of patients achieved pain freedom when taking placebo. There was an 18% difference in the percentage of patients taking 200 mg vs placebo, a 10% difference in the percentage of patients taking 100 mg vs placebo, and a 7% difference in patients taking 50 mg vs placebo.

Image 2: Pain Freedom at 90 Minutes

Results from the SAMURAI and SPARTAN studies representing the percentage of patients who achieved migraine pain freedom at 1.5 hours with REYVOW vs placebo.

In the SAMURAI study, 503 patients took 200 mg of REYVOW, 498 patients took 100 mg of REYVOW, and 515 patients took placebo. At 1.5 hours, 25% of patients achieved pain freedom when taking 200 mg, 20% of patients achieved pain freedom when taking 100 mg, and 10% of patients achieved pain freedom when taking placebo. At 1.5 hours, there was a 15% 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.

In the SPARTAN study, 521 patients took 200 mg of REYVOW, 523 patients took 100 mg of REYVOW, 544 patients took 50 mg of REYVOW, and 534 patients took placebo. At 1.5 hours, 28% of patients achieved pain freedom when taking 200 mg, 22% of patients achieved pain freedom when taking 100 mg, 18% of patients achieved pain freedom when taking 50 mg, and 13% of patients achieved pain freedom when taking placebo. At 1.5 hours, there was a 15% difference in the percentage of patients taking 200 mg vs placebo, a 9% difference in the percentage of patients taking 100 mg vs placebo, and a 5% difference in the percentage of patients taking 50 mg vs placebo.

The results for pain freedom at timepoints before 2 hours are descriptive and the analyses were not controlled for Type I error. The effect of REYVOW on pain freedom at these earlier timepoints cannot be regarded as statistically significant.

Image 3: Pain Freedom at 60 Minutes

Results from the SAMURAI and SPARTAN studies representing the percentage of patients who achieved migraine pain freedom at 1 hour with REYVOW vs placebo.

In the SAMURAI study, 503 patients took 200 mg of REYVOW, 498 patients took 100 mg of REYVOW, and 515 patients took placebo. At 1 hour, 14% of patients achieved pain freedom when taking 200 mg, 9% of patients achieved pain freedom when taking 100 mg, and 7% of patients achieved pain freedom when taking placebo. At 1 hour, there was a 7% difference in the percentage of patients taking 200 mg vs placebo and a 2% difference in the percentage of patients taking 100 mg vs placebo.

In the SPARTAN study, 521 patients took 200 mg of REYVOW, 523 patients took 100 mg of REYVOW, 544 patients took 50 mg of REYVOW, and 534 patients took placebo. At 1 hour, 17% of patients achieved pain freedom when taking 200 mg, 11% of patients achieved pain freedom when taking 100 mg, 7% of patients achieved pain freedom when taking 50 mg, and 7% of patients achieved pain freedom when taking placebo. At 1 hour, there was a 10% difference in the percentage of patients taking 200 mg vs placebo, a 4% difference in the percentage of patients taking 100 mg vs placebo, and a 0% difference in the percentage of patients taking 50 mg vs placebo.

View Clinical Study Design

Experts talk REYVOW efficacy

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 adults¹

REYVOW CAN PROVIDE PAIN FREEDOM FOR PATIENTS WITH MODERATE TO SEVERE MIGRAINE ATTACKS EVEN WHEN TAKEN LATER IN THE ATTACK¹²

Complete elimination of pain is possible, even for patients who wait up to 4 hours to dose REYVOW¹²

In a post hoc analysis, % of patients who achieved pain freedom at 2 hours by time to dosing¹²

Efficacy based on time to dosing — A post hoc analysis of SAMURAI and SPARTAN assessed patients who achieved pain freedom at 2 hours based on time to dosing.

2709 patients dosed between 0 and 2 hours from migraine onset, when pain was moderate to severe. 757 patients took 200 mg of REYVOW, 746 patients took 100 mg of REYVOW, 424 patients took 50 mg of REYVOW, and 782 patients took placebo. 35% of patients achieved pain freedom at 2 hours when taking 200 mg of REYVOW, 31% of patients achieved pain freedom at 2 hours when taking 100 mg of REYVOW, 31% of patients achieved pain freedom at 2 hours when taking 50 mg of REYVOW, and 19% of patients achieved pain freedom at 2 hours when taking placebo.

929 patients dosed between 2 and 4 hours from migraine onset, when pain was moderate to severe. 267 patients took 200 mg of REYVOW, 275 patients took 100 mg of REYVOW, 120 patients took 50 mg of REYVOW, and 267 patients took placebo. 36% of patients achieved pain freedom at 2 hours when taking 200 mg of REYVOW, 27% of patients achieved pain freedom at 2 hours when taking 100 mg of REYVOW, 20% of patients achieved pain freedom at 2 hours when taking 50 mg of REYVOW, and 15% of patients achieved pain freedom at 2 hours when taking placebo.

This is a post hoc analyses of pooled data from SAMURAI and SPARTAN. The analyses are considered exploratory and have not been controlled for Type I error. No conclusions of statistical significance can be drawn. Patients were instructed to take their dose when pain was moderate or severe and within 4 hours of onset of pain. The study did not stratify by time to dosing.

View Clinical Study Design

SELECT IMPORTANT SAFETY INFORMATION

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.

For the acute treatment of migraine with or without aura in adults¹

REYVOW CAN DELIVER FAST AND COMPLETE ELIMINATION OF THE MOST BOTHERSOME SYMPTOM (MBS) AT 2 HOURS WITH A SINGLE DOSE^1,13

MBS was defined as the self-identified most bothersome migraine-associated symptom of photophobia, phonophobia, or nausea.^1,13

Results from 2 studies, % of patients who achieved MBS freedom at 2 hours with REYVOW vs placebo — The results of the percentage of patients in SAMURAI and SPARTAN who achieved freedom from their most bothersome symptom (MBS) at 2 hours with REYVOW vs placebo.

In the SAMURAI study, 467 patients took 200 mg of REYVOW, 464 patients took 100 mg of REYVOW, and 480 patients took placebo. At 2 hours, 41% of patients achieved freedom from their MBS when taking 200 mg, 41% of patients achieved freedom from their MBS when taking 100 mg, and 30% of patients achieved freedom from their MBS when taking placebo. At 2 hours, there was an 11% difference in the percentage of patients who achieved freedom from MBS when taking 200 mg of REYVOW vs placebo (P<.001 vs placebo) and a 12% difference in the percentage of patients who achieved freedom from MBS when taking 100 mg of REYVOW vs placebo (P<.001 vs placebo).

In the SPARTAN study, 478 patients took 200 mg of REYVOW, 491 patients took 100 mg of REYVOW, 502 patients took 50 mg of REYVOW, and 509 patients took placebo. At 2 hours, 49% of patients achieved freedom from their MBS when taking 200 mg, 44% of patients achieved freedom from their MBS when taking 100 mg, 41% of patients achieved freedom from their MBS when taking 50 mg, and 33% of patients achieved freedom from their MBS when taking placebo. At 2 hours, there was a 16% difference in the percentage of patients taking 200 mg of REYVOW vs placebo (P<.001 vs placebo), an 11% difference in the percentage of patients taking 100 mg of REYVOW vs placebo (P<.001 vs placebo), and an 8% difference in the percentage of patients taking 50 mg of REYVOW vs placebo (P=.014 vs placebo).

View Clinical Study Design

SELECT IMPORTANT SAFETY INFORMATION

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. Discontinue REYVOW if serotonin syndrome is suspected.

See how REYVOW performed in another clinical study

SEE MORE DATA

References:

REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Migraine: developing drugs for acute treatment – guidance for industry. US Food and Drug Administration website. https://www.fda.gov/media/89829/download . Updated February 2018. Accessed August 26, 2020.
Silberstein SD, Newman LC, Marmura MJ, Nahas SJ, Farr SJ. Efficacy endpoints in migraine clinical trials; the importance of assessing freedom from pain. Curr Med Res Opin. 2013:29:861-867.
Kuca B, Silberstein SB, Wietecha L, Berg PH, Dozier G, Lipton RB. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91:e2222-e2232.
Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142:1894-1904.
Shapiro RE, Hochstetler HM, Dennehy EB, et al. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019;20:90.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0018.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0005.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0012.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0014.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0004.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0008.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0002.

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.

EXPLORE WHAT'S POSSIBLE WITH REYVOW1

Collapse accordion Clinical Trial Design

Clinical Study Design: SAMURAI AND SPARTAN

Collapse accordion Pain Relief

EFFECT OF REYVOW ON PAIN RELIEF1,10

Collapse accordion Pain Freedom

PAIN RELIEF IS NOT THE SAME AS PAIN FREEDOM

PAIN FREEDOM IS POWERFUL. REYVOW CAN HELP YOUR PATIENTS ACHIEVE IT AT 2 HOURS1,11

Experts talk REYVOW efficacy

Collapse accordion Time to Dosing

REYVOW CAN PROVIDE PAIN FREEDOM FOR PATIENTS WITH MODERATE TO SEVERE MIGRAINE ATTACKS EVEN WHEN TAKEN LATER IN THE ATTACK12

Collapse accordion Most Bothersome Symptom

REYVOW CAN DELIVER FAST AND COMPLETE ELIMINATION OF THE MOST BOTHERSOME SYMPTOM (MBS) AT 2 HOURS WITH A SINGLE DOSE1,13

See how REYVOW performed in another clinical study

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

ABUSE

INDICATIONS

EXPLORE WHAT'S POSSIBLE WITH REYVOW¹

EFFECT OF REYVOW ON PAIN RELIEF^1,10

PAIN FREEDOM IS POWERFUL. REYVOW CAN HELP YOUR PATIENTS ACHIEVE IT AT 2 HOURS^1,11

REYVOW CAN PROVIDE PAIN FREEDOM FOR PATIENTS WITH MODERATE TO SEVERE MIGRAINE ATTACKS EVEN WHEN TAKEN LATER IN THE ATTACK¹²

REYVOW CAN DELIVER FAST AND COMPLETE ELIMINATION OF THE MOST BOTHERSOME SYMPTOM (MBS) AT 2 HOURS WITH A SINGLE DOSE^1,13