FDA Approves Expanded Label of Allergan’s Botox to Treat Upper Limb Spasticity

FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.

On July 29, 2021, Allergan, an AbbVie company, announced that FDA approved a label expansion of Botox to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include:

  • Additional muscles of the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus)
  • Intrinsic hand muscles (lumbricals and interossei)
  • Thumb muscles (flexor pollicis brevis and opponens pollicis).

The label also includes the use of ultrasound as a muscle localization technique in adult spasticity.

Botox has been proven to significantly reduce muscle stiffness and is indicated for the treatment of spasticity in patients two years of age and older, according to the company. With this expanded dosing guidance, physicians can treat based on an assessment of a patient’s spasticity and anatomy while staying within the Botox maximum cumulative dose of 400 units in a three-month period in adults.

Stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury commonly cause spasticity in adults. Upper limb spasticity can manifest as a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist.

"Botox has demonstrated efficacy and safety for spasticity management at clinically proven doses," said Kimberly Heckert, director, spasticity management fellowship, Thomas Jefferson University of Philadelphia. "This label expansion offers physicians and their patients living with spasticity another important tool as part of a comprehensive treatment plan for spasticity management."

Source: Abbvie