Ipsen: Dysport Demonstrates Non-Inferiority to Botox in DIRECTION Study
Ipsen announced on Tuesday the results of the phase IV DIRECTION study, the first direct double-blind comparison between its products Dysport and Botox in adults with upper limb spasticity. The data met its primary and secondary endpoints and will be presented at the ISPRM World Congress in Vancouver.
Non-Inferior Safety Profile and Longer Duration of Effect for Dysport
The DIRECTION study shows that Dysport (abobotulinumtoxinA) has a non-inferior safety profile compared to Botox (onabotulinumtoxinA), with an adverse event rate of 20.3% for Dysport versus 23.0% for Botox. In terms of efficacy, patients treated with Dysport experienced a longer duration of effect than those treated with Botox (14.2 weeks versus 13.8 weeks, respectively). This difference was consistent across most demographic and clinical subgroups.
Trial Methodology and Studied Population
The DIRECTION trial was conducted with 464 adult patients suffering from upper limb spasticity, across 72 centers in the United States, France, and Canada. The participants had an average age of 57 years, two-thirds were men, and the majority had spasticity following a stroke. Each patient received one treatment cycle with each toxin, administered using standardized techniques guided by instrumentation. The study controlled for factors that could influence outcomes, including volume, dilution, dose, and treated muscles.
