BY ED SUSMAN
LISBON, Portugal—The investigative agent lasmiditan relieves patients' most bothersome migraine symptoms within two hours of dosing, researchers reported here at the Congress of the European Academy of Neurology.
The so-called SPARTAN study was the second of two pivotal phase 3 trials evaluating lasmiditan in migraine patients with and without aura. In the large phase 3 trial, 48.7 percent of the 528 patients assigned to the 200 mg dose of lasmiditan in the modified intent-to-treat analysis said they were free of their most bothersome migraine symptom — usually light sensitivity — at two hours, compared with 33.5 percent of 540 placebo patients (p<0.001).
The study participants averaged five or more migraine attacks a month during the previous three months. About 37 percent had migraines accompanied by aura, about 18 percent used prophylactic medication to prevent migraine attacks, and on average they had migraines for 18 years. More than 75 percent of the patients had at least one cardiovascular risk factor.
“Higher doses of lasmiditan separated from placebo as early as one hour for pain-free achievement and within 30 minutes for relief of the most bothersome symptom,” reported Sheena Aurora, MD, medical fellow and launch leader on the pain team for Lilly Bio-Medicines of Eli Lilly and Company in Indianapolis.
About 38.8 percent of patients taking the 200 mg dose of lasmiditan achieved pain-free status within two hours compared with 21.3 percent of patients on placebo (p<0.001), she said.
Among other findings, 31.4 percent of patients on the 100 mg dose of the dose also achieved the pain-free milestone in two hours, which was also significantly superior to placebo (p<0.001); 28.8 percent of patients on the 50 mg dose were free of pain at two hours (p=0.03), Dr. Aurora said in her oral presentation.
Dr. Aurora said the drug was generally well tolerated. Most common side effects were dizziness, paresthesias, and somnolence, she noted.
Dr. Aurora added that the company was planning to file a new drug application for lasmiditan by the end of 2018.
Commenting on the study, Noah Rosen, MD, director of Northwell Health's Headache Center in Great Neck, NY, told the Neurology Today Conference Reporter: “Up until now, the only migraine specific acute medications we have had have been the triptans, which block 5HT1b and d receptors. Even then they are not truly migraine specific as other conditions, such as cluster headache, which also respond to their use.”
“While triptans are arguably the most important leap forward in the 20th century with regards to the management of migraine, they also have significant limitations,” he said. “These include the relative contraindications of coronary artery disease, cerebrovascular disease, and peripheral vascular disease.”
“The advent of lasmiditan, which preferentially affects the 5HT1f receptor, should, in theory, be less of a cardiovascular risk as that receptor is not represented on salient blood vessels,” he said, disclosing that he has consulted for Eli Lilly although he was not a participant in the current trial. “As such, lasmiditan may not only be as effective as a triptan, but also less of a questionable risk in people with known risk factors for cardiovascular disease.”
He said that when approved lasmiditan will “expand our armamentarium for the acute treatment of migraine. It is often the case that individuals can’t tolerate medications either due to side effects or a lack of efficacy.”
“Having this medication allows us other opportunities to manage migraines in that refractory population,” Dr. Rosen said.
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