FDA Approves Botox Label Expansion for Upper Limb Spasticity

The US Food and Drug Administration (FDA) has approved a label expansion of onabotulinumtoxinA (Botox) to include 8 new muscles in the treatment of upper limb spasticity in adults.

These additional muscles are brachialis, brachioradialis, pronator teres, and pronator quadratus in the elbow and forearm; lumbricals and interossei in the hand; and flexor pollicis brevis and opponens pollicis in the thumb.

The expanded label also includes the use of ultrasound as a muscle localization technique for these patients.

"Today's announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient's quality of life," said Mitchell Brin, MD, Senior Vice President and Chief Scientific Officer of BOTOX® & Neurotoxins at AbbVie, in a statement.

"This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients."

About Upper Limb Spasticity

Adults may develop spasticity following stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Such individuals are likely to experience stiffness in the muscles of their upper and/or lower limbs and may lose voluntary control of them.

Signs of upper limb spasticity include a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist. These can lead to difficulty with posture and positioning and can largely impact the patient’s daily functioning and activities.

It is estimated that 6.7 million adults in the United States live with spasticity across a variety of neurologic conditions.

OnabotulinumtoxinA is currently approved for treatment of spasticity in patients 2 years of age and older.