Injection Now Indicated for Upper Limb Spasticity
The FDA has expanded the use of abobotulinumtoxinA injection (Dysport).
The FDA has expanded the use of Ipsen Biopharmaceuticals’ abobotulinumtoxinA injection (Dysport), permitting the drug to be prescribed for the treatment of upper limb spasticity (ULS) in adult patients.
Dysport was previously approved for the treatment of adults with cervical dystonia and for the reduction of glabellar lines. Now, it is the first ULS therapy to receive FDA approval in the past 5 years. With this latest nod, patients will be able to use the drug to decrease the severity of increased muscle tone in elbow, wrist, and finger flexors.
“It is estimated that 1.8 million adult Americans may suffer from spasticity, which in the upper arm can cause muscle stiffness, flexing, spasms, twitching and pain,” said Ipsen CEO Cynthia Schwalm in a press release. “We are pleased to offer another treatment option for those individuals with ULS, a debilitating condition that often comes on the heels of a traumatic health event such as a stroke or brain injury.”
The FDA based its approval on data from a phase 3 clinical trial that evaluated the drug’s safety and efficacy as a ULS treatment in 238 adult hemiparetic patients with ULS following stroke or brain trauma. At week 4, both the 500- and 1000-unit doses of Dysport significantly reduced muscle tone in approximately 3 of 4 patients, with some experiencing clinical improvement after 1 week. The majority were retreated between 12 and 16 weeks, but some had a response duration of up to 20 weeks.
“This approval is based on strong data which showed that Dysport improved muscle tone in the upper limb—essential for active use of the hand and arm," stated Allison Brashear, MD, the US principal investigator of the phase 3 trial. "It is important to realize that early identification is critical for patients with upper limb spasticity, given that when left untreated, spasticity can result in increased muscle tone”
The most common adverse reactions reported by trial participants were urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall, and depression; however, there were no differences in the rate of serious adverse events between the placebo and Dysport groups.
Like all botulinum toxin products, Dysport has a Boxed Warning stating that its effects may spread from the area of injection to other areas of the body, causing potentially life-threatening symptoms such as swallowing and breathing difficulties.