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Dysport (abobotulinumtoxinA) Gets FDA Approval for Lower Limb Spasticity

June 19, 2017
New approval will help adults who develop spasticity from stroke, traumatic brain injury, spinal cord injury, multiple sclerosis, and cerebral palsy.

The FDA has approved Dysport (abobotulinumtoxin A) IV for the treatment of spasticity in adults. Dysport, manufactured by Ipsen Biopharmaceuticals, previously was approved for the management of adults with cervical dystonia and for lower limb spasticity in pediatric patients 2 years of age and older.

According to a press release from the company, the approval of Dysport was based on its Biologics License Application in lower limb spasticity.1 In a Phase 3 trial, 381 adult patients were randomized to recieve Dysport 1,000 Units (n=125), Dysport 1,500 Units (n=128), or placebo (n=128) injected intramuscularly into the gastrocnemius-soleus muscle complex located in the calf. Some of the lower limb muscles injected during the study included: tibialis posterior, flexor digitorum longus, and/or flexor hallucis longus.

Patients who suffer a stroke often develop spasticity. The approval of Dysport provides another option for the treatment of spasticity in post-stroke patients.

Patients who received Dysport after having a stroke or traumatic brain injury demonstrated "improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale (MAS). There was improvement in both the mean change from baseline in MAS score at the ankle joint at Week 4 (MAS treatment difference vs. placebo were: -0.5 for placebo, -0.6 for Dysport 1000 Units (NS6), and -0.8 for Dysport 1500 Units (P<0.05). The duration of response was between 12 and 16 weeks. In this study, some patients experienced a longer duration of response (approximately 20 weeks)," reported the company.

In adults, approximately 1 in 3 stroke patients, 1 in 3 patients with spinal cord injury, 1 in 6 patients with traumatic brain injury, and 2 in 3 patients with multiple sclerosis will develop lower limb spasticity.2,3

Adverse Events

The most common adverse reactions in adults for Dysport 1,000 Units, Dysport 1,500 Units, and placebo, respectively, were: falls (9%, 6%, 3%), muscular weakness (2%,7%, 3%), pain in extremity (6%, 6%, 2%). Muscular weakness was reported more frequently in women (10%) treated with 1,500 Units of Dysport compared to men (5%).

Dysport and all botulinum toxin products have 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. The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products."1

About Dysport

According to Ipsen, 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.

“Dysport is currently the only botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower limbs and also for the treatment of lower limb spasticity in children ages two and older,” said Cynthia Schwalm, president of North America Commercial Operations, Ipsen. “We are proud that Dysport is now available to support an additional population of patients— including those adults managing their spasticity associated with stroke, brain injury, spinal cord injury, multiple sclerosis, or cerebral palsy—and that Ipsen is able to provide comprehensive support offerings, including the IPSEN CARES patient assistance program and the C.L.I.M.B. injector training platform for healthcare providers.”

 

Last updated on: June 19, 2017
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