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news.Irish pharmaceutical firm Actavis has secured approval from the US Food and Drug Administration (FDA) for expansion of the BOTOX (onabotulinumtoxinA) label to treat adults with upper limb spasticity, a debilitating neurological condition.
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The expanded label now includes the addition of two thumb muscles: flexor pollicis longus and adductor pollicis; increasing the maximum dose from 360 to 400 units to teat upper limb spasticity.
The agency has also approved an increase to the maximum BOTOX cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
BOTOX is the first and only neurotoxin approved by the agency to treat upper limb spasticity that produces muscle stiffness that can result in tight muscles in the elbow, wrist and fingers including thumb.
In patients aged 18 years and older, BOTOX, a prescription medicine, is injected into muscles and used to treat increased muscle stiffness in elbow, wrist and finger muscles.
Wake Forest Baptist Medical Center professor and chair Department of Neurology and lead clinical trial investigator Allison Brashear said: "Simple tasks such as washing the affected hand or getting dressed can be limiting for patients with the condition, and they’re often left to depend on a caregiver to help them.
"It’s important for patients experiencing these types of symptoms to talk to their doctor who can refer them to a neurologist or physiatrist to discuss their treatment options."
The expanded label approval is based on two additional randomized, multi-center, double-blind, placebo-controlled trials evaluating the efficacy and safety of BOTOX in patients with upper limb spasticity.