Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.
“In the clinical studies, we saw improvement in muscle tone in patients injected with BOTOX®, which was maintained for up to three months with no further injection.”
Spasticity is a debilitating condition impacting approximately 1 million Americans, many of whom suffer from spasticity in the upper limbs following a stroke. Upper limb spasticity may also occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy.
Although not a life-threatening condition, upper limb spasticity can be severely debilitating and painful, producing disfiguring muscle contractions that can result in stiff, tight muscles in the elbow, wrist and fingers, or a clenched fist. This stiffness hinders a patient’s ability to perform simple tasks, such as dressing or washing the hand, and often leaves the patient dependent on a caregiver to help with simple activities.
“Upper limb spasticity can manifest weeks, months or even years after the original injury, possibly after a patient has stopped seeing a neurologist, physiatrist or their rehabilitation specialist, which is why it is severely undertreated and there’s a low awareness of the condition,” said Mitchell F. Brin, MD, Allergan’s Senior Vice President Global Development, Chief Scientific Officer, BOTOX®. “The approval of BOTOX® marks another important evolution in medical care, as we look to raise greater recognition and understanding of upper limb spasticity among patients affected by the condition, and refer them to a neurologist or physiatrist to explore their various treatment options.”
In patients diagnosed with upper limb spasticity, BOTOX® is injected by a trained specialist directly into the affected muscles, blocking overactive nerve impulses that trigger these disabling contractions to reduce the severity of increased muscle tone in the elbow, wrist and fingers. In clinical studies, the efficacy of BOTOX® persisted up to three months on average. BOTOX® is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity.
Clinical Studies Evaluating BOTOX® For the Treatment of Upper Limb Spasticity
Allergan has conducted multiple studies evaluating the use of BOTOX® to treat upper limb spasticity, including three double-blind, placebo-controlled studies, two of which were published in The New England Journal of Medicine, and Archives of Physical and Medical Rehabilitation.
The first double-blind, placebo-controlled trial compared the safety and efficacy of BOTOX® treatment (200-240 units (U)) with placebo over a 12-week period in 126 patients who had suffered a stroke at least 6 months prior and experienced increased wrist and finger flexor tone (scores of at least 3 for wrist flexor tone and at least 2 for finger flexor tone based on the Ashworth Scale). The Ashworth Scale is a globally accepted measure of muscle tone, which rates passive movement from 1 (normal muscle tone) to 4 (extreme increase in muscle tone).