Dysport Approved for Lower Limb Spasticity

Thursday, June 22, 2017

The FDA has expanded the indication of Dysport (abobotulinumtoxinA, Ipsen Biopharmaceuticals) to include lower limb spasticity. In a Phase 3 study, adult patients treated with Dysport following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint at four weeks. The duration of response for the majority of patients was between 12 to 16 weeks, while some patients experienced response for as long as 20 weeks.

Repeat Dysport treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection, according to Ipsen. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport and muscles to be injected.

In July 2015, Dysport was approved for the treatment of upper limb spasticity in adults. In July 2016, Dysport was approved to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin that the FDA approved for this indication.

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