FDA Approves Botox For Muscle Spasms Treatment

By Margarita Nahapetyan

The U.S. FDA (Food and Drug Administration) has now approved Allergan Inc.'s (AGN) Botox for the treatment of muscle spasms in the elbows, wrists and fingers in individuals who suffer the condition, called upper limb spasticity.

Botox (onabotulinumtoxin A) was designed to block nerve impulses to certain muscles, making them to relax. The chemical works by preventing the connections between nerves and muscles, temporarily causing the paralysis of the spastic muscle. The drug is a purified form of botulinum, known as the most toxic substance in the world. Botox, mostly popular in cosmetic use to smooth facial wrinkles and fine lines, is also approved for the treatment of cervical dystonia, or uncontrolled muscle contractions of the neck and shoulder muscles, and for the treatment of excessive underarm sweating.

According to the FDA, limb spasticity generally occurs after stroke, traumatic brain injury or the progression of multiple sclerosis. Although the condition does not appear to be life-threatening, upper limb spasticity can be severely debilitating and painful, causing disfiguring muscle contractions that are associated with tight muscles in the elbow, wrist, fingers, or a clenched fist. This stiffness interferes with a person's ability to perform regular and simple activities, such as getting dressed or washing the face, and often results in the patient's dependence on other people to help with simple tasks.

FDA stated in their report that treatment with Botox is not intended to be a substitute for physical therapy or other treatments prescribed to patients by their physicians, and that Botox is not safe for use in treating other upper limb muscles, spasticity in the legs, or for treatment of fixed contracture (a condition that interferes with range of motion). In those diagnosed with upper limb spasticity in the elbow, wrist and fingers, Botox is being administered by a qualified professional directly into the affected muscles, therefore blocking overactive nerve impulses that cause these disabling contractions, and decrease the severity of increased muscle tone. Clinical studies have demonstrated that the efficacy of Botox lasts for up to three months on average.

Dr Mitchell Brin, chief scientific officer for Botox and Allergan's senior vice-president of global development, said that this new approval by FDA is a positive step in treating a debilitating and underexposed condition. He also noted that the approval of the drug marks another important evolution in the history of medicine, "as we look to raise greater recognition and understanding of upper limb spasticity among patients affected by the condition."

However, even though Botox was only recently approved by the Food and Drug Administration for the treatment of upper limb spasms, it is not a secret that many doctors have been prescribing the drug to their patients for this purpose for some time. By law, Allergan cannot promote Botox for uses that have not been approved, but doctors are free to prescribe it for all kinds of off-label purposes.