Allegran plc announced last week that the U.S. Food and Drug Administration (FDA) has approved Botox to treat lower limb spasticity in adults.
Botox will be used to reduce muscle stiffness in ankle and toe muscles in patients. It is the first and, currently, the lone botulinum toxin that has been approved by the FDA to treat upper and lower limbs suffering from spasticity.
Botox was approved for adults in March of 2010 for use in elbows, wrists and fingers impacted by spasticity, also referred to as muscle tightness or stiffness. In April 2015 the FDA extended the approval to include two thumb muscles.
It remains unknown if the use of Botox is safe or effective when used to treat upper limb spasticity (ULS) in other muscles beside the elbow, wrist, fingers and thumb or in lower limb muscles other than those in the ankle or toes. Treating spasticity in any of these muscles is not a replacement for physical therapy or any other type of rehabilitation prescribed by medical professionals.
Spasticity is caused when muscle tone increases abnormally, causing stiffness and interfering with movement. It is usually caused by strokes, adult cerebral palsy, multiple sclerosis, brain and physical trauma or infection.