The US Food and Drug Administration (FDA) recently approved the use of BOTOX to help treat lower limb spasticity in adults following a stroke.

The approval is to help decrease the severity of increased muscle stiffness in ankle and toe muscles. It is stressed in the media release from Allergan that this treatment is not meant to replace existing physical therapy or other prescribed rehabilitation.

The approval was based on study evaluating the safety and efficacy of BOTOX compared to placebo in more than 400 patients with lower limb spasticity following a stroke. The participants received either a total BOTOX dose of 300 to 400 units divided among ankle and toe muscles (n=233) or a placebo (n=235).

Among the participants who received BOTOX treatment, statistically significant improvements were observed in the two co-primary endpoints of average change from baseline in the improvement of muscle tone measured by the Modified Ashworth Scale (MAS) ankle score and the clinical benefit for patients as assessed by the Clinical Global Impression of Change by Physician (CGI) at weeks 4 and 6 (p<0.05), the release explains.

According to the release, this recent approval means that BOTOX is now approved to treat both upper and lower limb spasticity. In March 2010, BOTOX was approved to help treat muscle stiffness in the elbows, wrists, and fingers. Then, in April 2015, BOTOX received FDA approval to help treat the two thumb muscles.

However, there are specific caveats to these approvals, the release explains: It is not known whether BOTOX is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

“In my experience, stroke survivors are among the most prominent groups to be impacted by spasticity affecting the upper and lower limbs; and it is critical to continue seeking treatment from a physician specially trained to manage spasticity,” says Alberto Esquenazi, MD, John Otto Haas Chair and Professor, Department of Physical Medicine and Rehabilitation; Director, Gait & Motion Analysis Laboratory, MossRehab, and a lead investigator in the studies, in the release.

For more information, visit Allergan.

[Source(s): Allergan, PR Newswire]