Data from Pharmawand - Curated by EPG Health - Date added 06 December 2017
Ipsen announced that detailed results from a Phase III randomized, double-blind, placebo-controlled study (NCT01249404) and its open-label extension study (NCT01251367) have been published in the current issue of Neurology, demonstrating the efficacy and safety of Dysport (abobotulinumtoxin A) in adult patients with lower limb spasticity following a stroke or traumatic brain injury. The international phase III registration study led to the FDA expanded approval of Dysport for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity, on 16 June 2017. This same study has been the basis for marketing authorization in other key markets, including the UK and Germany, in late 2016, and regulatory procedures are still ongoing in other countries.
These two studies demonstrated the efficacy and safety of Dysport in adults with hemiparesis who experienced lower limb spasticity. The results showed that, in this population, single Dysport administration reduced muscle tone, while repeated administration over a year was well-tolerated and improved both walking speed and likelihood of achieving community ambulation. In the U.S., Dysport has a boxed warning in its product label regarding distant spread of toxin effect.
See-Gracies JM, Esquenazi A, Brashear A, et al. "Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension: Data Supplement"