lasmiditan

Neurology· 715 cited findings· 1 source document

What the regulatory reviews say

Lasmiditan (International Non-proprietary Name: lasmiditan, ATC Code: N02CC) is an active substance developed by Eli Lilly Nederland B.V. for the acute treatment of the headache phase of migraine attacks, with or without aura in adults. It is administered orally in strengths of 50 mg, 100 mg, and 200 mg. The regulatory procedure number for this drug is EMEA/H/C/005332/0000.

In clinical trials, pain freedom at 2 hours post-dose ranged from 19.1% to 38.8%. For comparison, pain freedom at 2 hours post-dose with unspecific NSAIDs is 20-25%, and with triptans, it is 20% to 40%. A significant proportion of patients (30-40%) do not respond adequately to triptan therapy, and 30% fail to respond to a particular triptan. Pain relief at 2 hours post-dose was observed in 54.6% of patients. For recurrence, a second dose resulted in 50% pain freedom at 2 hours post-dose and 70.7% MBS-freedom at 2 hours post-dose.

Safety findings include hypoaesthesia at 2.3% (Phase 2/3 Pool). Discontinuation of triptan therapy due to side effects is reported at 29%. Lasmiditan showed a hERG current inhibition IC50 of 3.1 µM. The No Observed Adverse Effect Level (NOAEL) for lasmiditan in a dog cardiovascular function study was 6 mg/kg, and the No Observed Effect Level (NOEL) in a mouse CNS function study was 4 mg/kg.

Key figures — cited to the source page

Pain freedom at 2 hours post-dose	38.8	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.87
Pain freedom at 2 hours post-dose with triptans	20% to 40%	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.12
Pain freedom at 2 hours post-dose with unspecific NSAIDs	20-25%	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.12
Pain relief at 2 hours post-dose	54.6	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.85
Hypoaesthesia (Phase 2/3 Pool)	2.3	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.128
Discontinuation of triptan therapy due to side effects	29%	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.12
Lasmiditan hERG current inhibition IC50	3.1	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.23
Therapeutic indication	acute treatment of the headache phase of migraine attacks, with or without aura in adults	Eli Lilly and Company — Rayvow EMA EPAR public assessment re, p.2

Source documents

Eli Lilly and Company — Rayvow EMA EPAR public assessment report (EMEA/H/C/005332, 2022) (2022)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.