Botox Label Expanded to Include 8 New Muscles for Upper Limb Spasticity Treatment

The label now includes the use of ultrasound as a muscle localization technique in adults with spasticity, and includes muscles of the elbow, forearm, hand, and thumb.

Allergan/AbbVie’s onabotulinumtoxinA (Botox) has received FDA approval for an expanded indication to treat 8 additional new muscles in patients with upper limb spasticity. Among them include muscles of the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), intrinsic hand muscles (lumbricals and interossei), and thumb muscles (flexor pollicis brevis and opponens pollicis).

OnabotunlinumtoxinA, which has proven to significantly reduce muscle stiffness and is indicated for the treatment of spasticity in patients 2 years of age and older, also now includes the use of ultrasound as a muscle localization technique for adults with spasticity. The therapy has been around since 1989, when it was first approved for 2 rare eye muscle disorders—blepharospasm and strabismus in adults.

"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,” Mitchell F. Brin, MD, senior vice president, chief scientific officer, Botox and Neurotoxins, AbbVie, said 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."

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The expanded dosing guidance allows clinicians to continue to treat patient’s spasticity while staying within the maximum cumulative dose of 400 units in a 3-month period for adults. Additionally, the new indication has no effect on the safety profile of the therapy, with the most common adverse events (AEs) that still include nausea, fatigue, bronchitis, pain in extremity, and muscular weakness.

In addition to treating adult and pediatric spasticity, onabotulinumtoxinA has been greenlighted for therapeutic indications such as chronic migraine, overactive bladder, incontinence due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, severe axillary hyperhidrosis and pediatric detrusor overactivity associated with a neurologic condition.

"Botox® has demonstrated efficacy and safety for spasticity management at clinically proven doses," Kimberly Heckert, MD, director, Spasticity Management Fellowship, Thomas Jefferson University, said in a statement. “This label expansion offers physicians and their patients living with spasticity another important tool as part of a comprehensive treatment plan for spasticity management.”

The FDA cleared the therapy’s use for treating pediatric patients with upper limb spasticity in June 2019. It became the first neurotoxin approved to treat pediatric patients with upper limb spasticity and was backed by data from 2 phase 3 studies that evaluated the safety and efficacy in more than 200 patients in this population. OnabotulinumtoxinA’s most recent FDA approval was to treat neurogenic detrusor overactivity(NDO) in pediatric patients aged 5 years or older that are intolerant of or do not respond well to anticholinergic medication. The agent was originally approved for the treatment of adult NDO in 2011. The cause of NDO in children can include transverse myelitis, spinal cord injury, spina bifida, and multiple sclerosis.

There have been several ongoing trials that have evaluated the therapy in combination with other preventives in patients with chronic migraine. Andrew Blumenfeld, MD, director, Headache Center of Southern California, recently sat down with NeurologyLive to discuss his research at the 2021 American Headache Society 63rd Annual Scientific Meeting, June 3-6, which evaluated the real-world safety and benefits of combining a calcitonin gene-related peptide monoclonal antibody and onabotulinumtoxinA. Listen to his comments below.

REFERENCES
1. FDA approves expanded Botox (onabotulinumtoxinA) label to include 8 new muscles to treat adults with upper limb spasticity. News release. Allergan/AbbVie. July 29, 2021. Accessed July 29, 2021. https://news.abbvie.com/news/press-releases/fda-approves-expanded-botox-onabotulinumtoxina-label-to-include-eight-new-muscles-to-treat-adults-with-upper-limb-spasticity.htm
2. FDA approves Botox (onabotulinumtoxinA) for pediatric patients with upper limb spasticity. News release. Allergan. June 21, 2019. Accessed July 29, 2021. https://www.prnewswire.com/news-releases/fda-approves-botox-onabotulinumtoxina-for-pediatric-patients-with-upper-limb-spasticity-300872470.html
3. BOTOX® (onabotulinumtoxinA) receives FDA approval for pediatric detrusor overactivity associated with a neurologic condition. News release. Allergan. Published online February 10, 2021. Accessed July 29, 2021. https://www.prnewswire.com/news-releases/botox-onabotulinumtoxina-receives-fda-approval-for-pediatric-detrusor-overactivity-associated-with-a-neurologic-condition-301225563.html