FDA Approves New Option for Lower Limb Spasticity

The FDA has expanded the approval of Dysport (abobotulinumtoxinA) injection for the treatment of lower limb spasticity in adults.

Dysport was originally approved in 2015 for the treatment of upper limb spasticity in adults, and in 2016 for pediatric patients aged 2 and older with lower limb spasticity.

In a Phase III, prospective, double-blind, randomized, placebo-controlled study, adults who were treated with Dysport following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint. The duration of response for the majority of patients was between 12 and 16 weeks.

Dysport treatment should be repeated when the effects of a previous injection have diminished. The most common adverse reactions in adults with lower limb spasticity were falls, muscular weakness, and pain in extremity.

—Michael Potts

Ipsen announces FDA approval of Dysport® (Abobotulinumtoxina) for the treatment of lower limb spasticity in adults [press release]. June 16, 2017. http://www.businesswire.com/news/home/20170616005486/en/Ipsen-Announces-FDA-Approval-Dysport%C2%AE-Abobotulinumtoxina-Treatment.