Overview
Lasmiditan is an oral medication used in the termination of migraine headaches that was first approved for use in the United States in October 2019. It was also approved by the European Commission on August 17, 2022. Traditionally, the triptan class of anti-migraine medications (e.g. sumatriptan) have seen preferential use in the acute treatment of migraines due to their relatively favourable efficacy and safety. Their use is not devoid of concerns, however, and their vasoconstrictive activity can lead to blood pressure lability and other cardiovascular side effects - for this reason, these medications are less suitable for use in patients with pre-existing cardiovascular disorders. Triptans abort migraines via action at several serotonin receptors, including 5-HT and 5-HT receptors, and activity at the 5-HT receptor has been specifically implicated in their vasoconstrictive activity. Lasmiditan, in contrast, is a highly selective agonist of 5-HT receptors, carrying virtually no affinity for other receptors which appear to be largely responsible for the adverse effect profile of its predecessors - in other words, lasmiditan’s selectivity allows for the successful termination of migraines without causing vasoconstriction. Selectivity for 5-HT, a lack of vasoconstrictive activity, and the ability to terminate migraines through neuronal inhibition has resulted in the creation of a new class of anti-migraine medications in which lasmiditan is the first and only member: the neurally-acting anti-migraine medications (NAAMAs).
Indication
Lasmiditan is indicated for the acute treatment of migraine with or without aura in adults.
Associated Conditions
- Migraine Headache, With or Without Aura
Research Report
Comprehensive Monograph: Lasmiditan (Reyvow)
Section 1: Executive Summary & Therapeutic Context
1.1 Introduction to Lasmiditan
Lasmiditan, marketed under the brand name Reyvow, is a first-in-class, orally administered small molecule medication developed for the acute treatment of migraine.[1] It represents a new therapeutic category known as "ditans" and functions as a selective serotonin 5-hydroxytryptamine receptor 1F (
5−HT1F) agonist.[3] Its approved indication is for the immediate, abortive treatment of migraine attacks, with or without aura, in adult patients.[1] It is critical to note that Lasmiditan is not indicated for the prophylactic, or preventive, treatment of migraine.[1]
1.2 The Unmet Need in Migraine Therapy
The development of Lasmiditan was driven by a significant unmet need within the landscape of migraine therapeutics. Migraine is a highly prevalent and debilitating neurological disorder, recognized as one of the leading causes of disability globally, affecting a substantial portion of the population and imposing a heavy healthcare burden.[6] For decades, the therapeutic cornerstone for acute migraine has been the triptan class of drugs, such as sumatriptan.[2] While effective for many, the utility of triptans is fundamentally limited by their mechanism of action. Triptans exert their primary therapeutic effect through agonism at
5−HT1B and 5−HT1D receptors.[1] The activation of
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/06/15 | N/A | Recruiting | |||
2021/05/11 | Phase 1 | Completed | |||
2021/02/11 | Phase 1 | Completed | |||
2020/05/20 | Phase 3 | Recruiting | |||
2020/05/20 | Phase 3 | Recruiting | |||
2020/01/06 | Phase 3 | Completed | |||
2019/09/09 | Phase 1 | Completed | |||
2019/06/17 | Phase 1 | Completed | |||
2019/05/24 | Phase 2 | Completed | |||
2018/09/14 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Eli Lilly and Company | 0002-4491 | ORAL | 100 mg in 1 1 | 2/22/2022 | |
Eli Lilly and Company | 0002-0632 | ORAL | 100 mg in 1 1 | 8/21/2020 | |
Eli Lilly and Company | 0002-0265 | ORAL | 50 mg in 1 1 | 8/21/2020 | |
Eli Lilly and Company | 0002-4312 | ORAL | 50 mg in 1 1 | 2/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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