GlaxoSmithKline has presented the results from a new study at The 15th Migraine Trust International Symposium demonstrate that the new fast disintegrating, 100mg tablet formulation of Imigran (sumatriptan succinate) delivered onset of relief in as fast as 20 minutes. Until now, clinical studies for oral triptans, including Imigran, showed onset of relief in as early as 30 minutes.
The results come from a pooled analysis of two pivotal studies showing that a 100 mg dose of Imigran provided onset of relief in as early as 20 minutes, and from 30 minutes with a 50 mg dose. In the European study, patients taking Imigran 100mg, even when it was taken after the pain became moderate to severe, experienced onset of relief in as early as 17 minutes. By two hours, 72 per cent of patients taking 100 mg experienced pain relief, a release from GSK said.
"Every minute of relief counts when a patient suffers from a migraine attack that can significantly impact one's quality of life and drastically interrupt their daily lives," said Reto Agosti, a neurology director at KopfwehZentrum Hirslanden Zürich, Switzerland. "Finding a therapy that effectively alleviates pain and works quickly is critical. These data show that Imigran does just that, offering promising news for migraine sufferers," he added.
The two double-blind, placebo-controlled, single-attack outpatient studies were conducted at 153 centres in the US and Canada, and 119 centres in Europe. A total of 2,696 patients, ages 18-65 years old, were enrolled (1,366 in the US and Canada; 1,330 in Europe). Patients were randomised to receive Imigran 100mg, 50mg or placebo and asked to report elapsed time to relief (mild or no pain) using a stopwatch device. The primary endpoint - time to onset of relief - was predefined as the earliest minute at which a significant difference was achieved and then the statistical difference was maintained through two hours. Pain relief was described as the reduction of moderate/severe pain to mild/no pain, the release added.
Migraines are a neurobiological disorder affecting 10-15 per cent of the adult population in developed countries each year. Without treatment, migraines can last from 4 to 72 hours.
The new fast disintegrating tablet formulation of Imigran has been approved for use in Sweden, Finland, Germany, The Netherlands, Norway, Switzerland, United Kingdom, Estonia and the United States for the treatment of migraine in adults with or without aura.