More than 20 years have passed without the launch of a new substance class for acute
migraine therapy.
Triptans were the latest class of substances which successfully passed all developmental stages with a significant antimigraine efficacy and a sufficient safety profile. New drugs with a better adverse event profile and at least similar efficacy are needed for
migraine subjects who cannot tolerate
triptans for attack treatment.
Lasmiditan is a novel highly specific
5-HT1F receptor agonist currently in clinical trials for acute
migraine therapy and devoid of vasoconstriction in coronary arteries as determined in a surrogate assay. In both phase II randomized, placebo-controlled trials in acute
migraine the primary endpoint was met. For the intravenous formulation a clear dose-dependent effect on
headaches could be determined.
Lasmiditan tablets in doses of 50-400 mg show significant
headache relief after 2 hours compared with placebo and improved accompanying symptoms. This substance is chemically clearly different from other antimigraine drugs, which is also reflected by its dose-dependent adverse event profile chiefly including
dizziness,
vertigo,
paresthesia and
fatigue. Adverse events are usually linked to the central nervous system. Future phase III clinical trials with an active
triptan comparator or in a preferential trial design will allow a better comparison of
lasmiditan and
triptans. They will also determine whether
lasmiditan will become available to the
migraine patient.