Ipsen: Dysport, First Botulinum Toxin Effective in Phase III Against Migraine

Both BEOND Trials Achieve Main Objectives

The E-BEOND and C-BEOND trials, which enrolled 1,510 patients across 120 centers, both achieved their primary endpoint: a statistically significant reduction in the monthly number of migraine days compared to placebo, measured between weeks 21 and 24. These results mark a first: Dysport is the first botulinum toxin to show statistically significant efficacy in Phase III for episodic migraine (defined as 6 to 14 migraine days per month). The BEOND program thus becomes the first Phase III study program to demonstrate the efficacy of a botulinum toxin in preventing both forms of the disease.

Tolerance Profile Consistent with Established Data

Dysport was well tolerated in both trials. The safety signals observed are consistent with the known profile of the product for its approved indications, with no new or unexpected signals identified. The BEOND trial extension program, in which all participants receive Dysport for two treatment cycles, will continue until week 48. Detailed results will be presented at a later scientific congress.