Migraine drug has quick onset of action

Jun 9 2016

By Lucy Piper

The drug TEV-48125, shown to be effective for chronic migraine in a phase II trial, appears to work within 3 to 7 days of injection, researchers report.

TEV-48125, a monoclonal antibody against calcitonin gene-related peptide, given at a higher dose of 900 mg (four injections of 225 mg/1.5 mL) once a month, first showed a difference compared with placebo after 3 days, with patients experiencing 3.08 fewer headache hours compared with an additional 0.36 hours with placebo.

At a lower dose of 675 mg (three 225 mg injections plus one placebo), a difference was evident after 7 days, with 7.28 fewer headache hours compared to 1.59 fewer with placebo.

"These data offer a glimpse of how quickly preventive treatment effects may occur for [calcitonin gene-related peptide] monoclonal antibodies in [chronic migraine]", Marcelo Bigal (Teva Pharmaceuticals, Frazer, Pennsylvania, USA) and colleagues write in Neurology.

They add that "[e]arly onset of efficacy may provide positive reinforcement for migraineurs and increase adherence to therapy".

After 1 week, migraine hours had fallen by 11.37 hours among the 85 patients randomly assigned to the higher dose of TEV-48125 and 9.08 hours among the 87 assigned to the lower dose. These improvements were both significant compared with the drop of 2.85 hours for the 89 placebo-treated patients and were sustained throughout the 3-month study.

For moderate-to-severe headache days, significant differences were seen after 1 week with the high dose, at 1.26 fewer days versus 0.77 with placebo , and after 2 weeks for both the low (1.34 fewer days) and high dose (1.51 fewer days) versus placebo (0.79 fewer days). Patients taking the 900 mg dose continued to show greater improvement compared with placebo into week 3.

Commenting on the findings in the journal, Volker Limmroth (Klinik für Neurologie und Palliativmedizin Köln-Merheim, Cologne, Germany) points out that the study does not answer how "clinically meaningful" a reduction of a few headache hours a week is.

Nevertheless, he says that the data are definitely still important. In addition to the relatively quick onset of biological effect, he notes that "unlike with many established drugs, we do not see the early onset of adverse events and later onset of clinical benefit, which often challenges patient adherence."

Also, as monoclonal antibodies do not cross the blood-brain barrier, he highlights the fact that the "critical therapeutic target is [...] located peripherally and not in the brain."

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