(Doctor appears on screen with title card bottom right: “CARRIE DOUGHERTY, MD; Associate Professor of Neurology, MedStar Georgetown University Hospital; Paid Spokesperson”)
Doctor Voiceover: I'm Carrie Dougherty. I am a headache specialist and neurologist. I'm associate professor of neurology at MedStar Georgetown University Hospital. And I work as a part of the MedStar Georgetown Headache Center.
(Video topic appears in middle with REYVOW logo at top and doctor’s name at bottom: “WHAT ROLE DOES PAIN FREEDOM PLAY WHEN EVALUATING AN ACUTE MIGRAINE TREATMENT? With CARRIE DOUGHERTY, MD”)
<Music Throughout>
(Doctor appears on screen with REYVOW logo and text, “Indications and Usage: 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. Please see additional safety information at the end of this video. Click the links below for access to the Full Prescribing Information and Medication Guide.”)
Doctor Voiceover: REYVOW is indicated for the acute treatment of migraine with or without aura in adults. REYVOW is not indicated for the preventive treatment of migraine.
(Doctor appears on screen)
Doctor Voiceover: I have to say in my clinic, when it comes to patient expectations, I often find that my patients are settling when it comes to acute treatment, that they may have over time learned to be complacent and satisfied with a medication that just provides pain relief but that doesn't provide pain freedom. And oftentimes when we talk about what the acute medications that they're using are providing, they describe it, that it helps, or that it prevents the pain from worsening. I have found over the past year that if I reflect on how I take a patient history, I wasn't asking the right questions. Oftentimes, I was satisfied when a patient was telling me, "My acute medication works, yeah, I'm happy with it." But when I ask, "Well, what does it do for you?” The descriptions that they give aren't what I would consider success.
(Text appears on screen: “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. Please see additional safety information at the end of this video.”)
Professional Voiceover: REYVOW does carry a driving restriction. In studies, more sleepiness was reported at 8 hours compared to placebo. So, patients should be advised not to engage in activities requiring complete mental alertness for at least 8 hours after each dose. If they're unable to do this, they should not be prescribed REYVOW.
(Doctor appears on screen)
(Text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.1-3”)
(Icon: Bubble with two figures within)
(Text:
4439 PATIENTS AGE 18 AND OLDER WERE DOSED (REYVOW=3177; PLACEBO=1262), INCLUDING THOSE WITH:
- ≥2 cardiovascular risk factors (41%)4
- Concomitant use of migraine preventive drugs (22%)1
- Concomitant use of serotonergic medication (22%)5
- Prior triptan exposure within the past 3 months (37%)6
ALL PATIENTS HAD:
- History of migraine for at least 1 year2,3
- 3-8 migraine attacks/month2,3
- MIDAS* score ≥11 (pooled median was 25)7
*Migraine Disability Assessment)
Doctor Voiceover: REYVOW was evaluated in two randomized double-blind, placebo-controlled, single-attack trials. They were labeled SPARTAN and SAMURAI. These studies evaluated more than 4,400 patients with migraine, with or without aura. Patients were instructed to take their dose of study medication within four hours of headache onset and when the pain was moderate to severe.
(New text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.1-3”)
(Icon: Bubble with medicine bottle within)
(Text: “Patients were allowed to take a rescue medication 2 hours after taking study drug; however, opiods, barbituates, 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”)
Doctor Voiceover: Patients were allowed to take a rescue medicine two hours after taking REYVOW, but they were not allowed to take opioids, barbiturates, triptans or ergots within 24 hours of taking REYVOW.
(New text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.1-3”)
(Icon: Bubble containing head within)
(Text: “Primary endpoint PAIN FREEDOM1; Complete elimination of moderate to severe headache pain at 2 hours; Patients were instructed to take the study drug within 4 hours of headache onset when the pain was moderate to severe1”)
Doctor Voiceover: In both SPARTAN and SAMURAI, the primary endpoint was pain freedom at two hours. It's important to understand the distinction between pain freedom and pain relief. Patients have a priority for the pain to be gone with their acute migraine treatment, not for just pain reduction. Oftentimes, in clinic, we don't make this distinction and don't ask enough questions to really characterize what degree of pain relief or pain resolution patients are achieving with their acute treatments.
(Doctor appears on screen with text along the bottom)
(Text: “For the acute treatment of migraine in adults1, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 2 HOURS WITH A SINGLE DOSE OF REYVOW1,8. UP TO 39% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 2 HOURS COMPARED TO UP TO 21% WITH PLACEBO ACROSS 2 STUDIES1,8”)
Doctor Voiceover: The effect of REYVOW on pain freedom is that it provided fast and complete elimination of migraine pain at all doses, compared with placebo, at two hours.
(Data appears on screen)
(Text: “FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 2 HOURS WITH A SINGLE DOSE OF REYVOW1,8; UP TO 39% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 2 HOURS COMPARED TO UP TO 21% WITH PLACEBO ACROSS 2 STUDIES1,8”)
(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 2 hours with REYVOW vs placebo1,8)
Doctor Voiceover: In SPARTAN, up to 39% of patients achieved pain freedom at two hours, compared to 21% of patients on placebo, and in SAMURAI, up to 32% of patients on REYVOW achieved pain freedom at two hours, compared to 15% of patients on placebo.
(Text appears on screen: “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. Please see additional safety information at the end of the video.”)
Professional Voiceover: 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.
(Doctor appears onscreen with text: “For the acute treatment of migraine in adults1, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 90 MINUTES WITH A SINGLE DOSE OF REYVOW1,8. UP TO 28% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 90 MINUTES COMPARED TO UP TO 13% WITH PLACEBO ACROSS 2 STUDIES1,8. The results for pain freedom at timepoints before 2 hours are descriptive and the analyses were not controlled for Type I error. Effect of REYVOW on pain freedom at these earlier timepoints cannot be regarded as statistically significant.”)
Doctor Voiceover: Some patients achieved pain freedom even earlier than two hours. Pain freedom in 90 minutes was possible. The results for pain freedom at time points before two hours are descriptive, and the analyses were not controlled for Type I error; thus, the effect of REYVOW on pain freedom at these earlier time points cannot be regarded as statistically significant.
(Data appears onscreen)
(Text: “For the acute treatment of migraine in adults1, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 90 MINUTES WITH A SINGLE DOSE OF REYVOW1,8. UP TO 28% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 90 MINUTES COMPARED TO UP TO 13% WITH PLACEBO ACROSS 2 STUDIES1,8.”)
(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 90 minutes with REYVOW vs placebo1,8)
Doctor Voiceover: In SPARTAN, up to 28% of patients achieved pain freedom at 90 minutes, compared to 13% of patients on placebo. In SAMURAI, up to 25% of patients achieved pain freedom in 90 minutes, compared to 10% of patients on placebo.
(Doctor appears onscreen with text: “For the acute treatment of migraine in adults1, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 60 MINUTES WITH A SINGLE DOSE OF REYVOW (200 mg)1,8. UP TO 17% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 60 MINUTES COMPARED TO UP TO 7% WITH PLACEBO1,8. The results for pain freedom at timepoints before 2 hours are descriptive and the analyses were not controlled for Type I error. Effect of REYVOW on pain freedom at these earlier timepoints cannot be regarded as statistically significant.”)
Doctor Voiceover: REYVOW provided pain freedom in 60 minutes for some patients taking 200 milligrams.
(Data appears onscreen)
(Text: “For the acute treatment of migraine in adults1, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 60 MINUTES WITH A SINGLE DOSE OF REYVOW (200 mg)1,8. UP TO 17% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 60 MINUTES COMPARED TO UP TO 7% WITH PLACEBO1,8.”)
(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 60 minutes with REYVOW vs placebo1,8)
Doctor Voiceover: In SPARTAN, up to 17% of patients taking 200 milligrams of REYVOW achieved pain freedom at 60 minutes, compared to 7% on placebo. In SAMURAI, up to 14% of patients taking 200 milligrams of REYVOW achieved pain freedom at 60 minutes, compared to 7% on placebo.
(Doctor appears onscreen)
Doctor Voiceover: The results of these clinical trials align with what patients are looking for when it comes to acute treatment for migraine. Fast elimination of pain by acute migraine medication is a priority for patients. They don't have time to wait around for their medication to be effective. Many patients in my practice are looking for acute treatment for their migraine that's fast and effective at providing pain freedom. And it's nice to have options that really reflect what their priorities are. Thank you for watching this video. If you're interested in watching other videos in the REYVOW Connect series, please reach out to your Lilly representative.
(Text appears on screen: “Safety Summary: REYVOW may cause significant driving impairment. Advise patients not to engage in activities requiring complete mental alertness, such as driving or operating machinery, for at least 8 hours after taking REYVOW. Patients who cannot do this should not take REYVOW. Be aware that patients may not be able to assess their degree of impairment. REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Use caution if REYVOW is used in combination with alcohol or other CNS depressants. Reactions consistent with serotonin syndrome have occurred in patients taking REYVOW who were not taking other drugs associated with serotonin syndrome. Discontinue REYVOW if you suspect serotonin syndrome. Overuse of acute migraine drugs may cause medication overuse headache, which may present as migraine-like daily headaches or a marked increase in attack frequency. Detoxification, including withdrawal of overused drugs and treatment of symptoms, may be necessary. Common side effects include dizziness, fatigue, paresthesia, sedation, nausea, vomiting, and muscle weakness. REYVOW contains lasmiditan, a Schedule V controlled substance, which has abuse potential. Evaluate patients for risk of drug abuse and watch for signs of REYVOW misuse or abuse. This is not the complete safety information for REYVOW. Please see the full Important Safety Information below. Click the links below for access to the full Prescribing Information and Medication Guide. LM HCP MSR 30JUN2021”)
Professional Voiceover: Safety Summary; REYVOW may cause significant driving impairment. Advise patients not to engage in activities requiring complete mental alertness, such as driving or operating machinery, for at least 8 hours after taking REYVOW. Patients who cannot do this should not take REYVOW. Be aware that patients may not be able to assess their degree of impairment. REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Use caution if REYVOW is used in combination with alcohol or other CNS depressants. Reactions consistent with serotonin syndrome have occurred in patients taking REYVOW who were not taking other drugs associated with serotonin syndrome. Discontinue REYVOW if you suspect serotonin syndrome. Overuse of acute migraine drugs may cause medication overuse headache, which may present as migraine-like daily headaches or a marked increase in attack frequency. Detoxification, including withdrawal of overused drugs and treatment of symptoms, may be necessary. Common side effects include dizziness, fatigue, paresthesia, sedation, nausea, vomiting, and muscle weakness. REYVOW contains lasmiditan, a Schedule V controlled substance, which has abuse potential. Evaluate patients for risk of drug abuse and watch for signs of REYVOW misuse or abuse. This is not the complete safety information for REYVOW. Please see the full Important Safety Information below. Click the links below for access to the full Prescribing Information and Medication Guide.
(Text appears on screen with REYVOW logo, Lilly logo, trademark statement, copyright info, and video number and date)
(Text:
References
- REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
- 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, Weitecha 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-0004.
PP-LM-US-0634 8/2021 ©Lilly USA, LLC 2021. All rights reserved. REYVOW® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.”)