FDA Expands Dysport Label to Include Lower-Limb Spasticity in Adults

Botulinum toxin product carries boxed warning

The FDA has expanded the approved uses of Dysport (abobotulinumtoxinA, Ipsen Biopharmaceuticals) for the treatment of lower-limb spasticity in adults. Dysport is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder.

In July 2015, Dysport was approved for the treatment of upper-limb spasticity in adults. One year later, it was cleared for the treatment of pediatric patients 2 years of age and older with lower-limb spasticity, making it the only botulinum toxin that the FDA has approved for this indication.

In a phase 3, multicenter, prospective, double-blind, randomized, placebo-controlled study, adults treated with Dysport after a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale (MAS) at week 4. The duration of response for the majority of patients in the study was between 12 to 16 weeks.

Lower-limb spasticity affects a patient’s movement. In adults, approximately one in three stroke patients, one in three spinal cord injury patients, one in six traumatic brain injury patients, and two in three multiple sclerosis patients will develop lower-limb spasticity. Adults with cerebral palsy also commonly experience spasticity in their lower limbs.

The labeling for Dysport and all botulinum toxin products included a boxed warning, which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life threatening. Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein

Source: Ipsen Biopharmaceuticals; June 16, 2017.