FDA Approves Injection for Upper Limb Spasticity

The Food and Drug Administration has approved a new injection for the treatment of upper limb spasticity in adults, according to the drug’s manufacturer.

Ipsen Biopharmaceuticals Inc. says Dysport (abobotulinumtoxinA) decreases the severity of increased muscle tone in elbow, wrist, and finger flexors. An estimated 1.8 million Americans suffer from spasticity, the symptoms of which are muscle stiffness, flexing, spasms, twitching, and pain.

The drug had previously been approved for cervical dystonia.

“Spasticity can have a profound impact on adult patients and their abilities to perform the most basic daily tasks,” said Cynthia Schwalm, Ipsen’s CEO.

The approval came after a Phase III study that compared the efficacy of Dysport versus placebo in hemiparetic patients following stroke or brain trauma. The trial also included patients who were botulinum toxin naïve or previously treated with botulinum toxin.

At four weeks, the 238 patients in the study were tested for muscle tone in the treated limb using the Modified Ashworth Scale (MAS) and also assessed using the Physician Global Assessment (PGA). The study showed improvement in both measurements for patients given doses of Dysport. Approximately three out of four patients responded to the drug, with significantly reduced muscle tone in the primary target muscle groups, which included elbow, wrist, and finger muscles.

“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,” said Allison Brashear, MD, professor and chair of neurology at Wake Forest Baptist Medical Center and the US principal investigator of the Phase III 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 frequently reported adverse reactions were urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall, and depression.