BioCentury
ARTICLE | Clinical News

Axert almotriptan: Phase III data; NDA under review; marketed in Spain

May 8, 2000 7:00 AM UTC

In a 1,173-patient Phase III trial, 58 percent of patients given a single dose of 12.5 mg Axert had pain relief after 2 hours versus 57 percent for patients given 50 mg of Glaxo Wellcome plc's Imitrex sumatriptan. Similar results were seen after 30 minutes and 1 hour. Side effects were experienced in 15 percent of the Axert group versus 19 percent of the Imitrex group, with significantly fewer chest pain symptoms reported with Axert.

In a separate 6-month, open-label 582-patient Phase III trial, patients experienced pain relief at 2 hours in 76 percent of 10,605 migraine attacks, and were pain free at 2 hours in 49 percent of the attacks. In 1,718 migraine relapses within 24 hours, patients taking a second dose experienced pain relief at 2 hours in 86 percent of cases, and were pain free in 59 percent. Adverse events included nausea and dizziness. ...