Allergan announced that the Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adults, to decrease the severity of increased muscle stiffness in ankle and toe muscles. 

Botox was initially approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist, and fingers. It later received FDA approval to expand the treatment of ULS to include the addition of 2 thumb muscles. 

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The approval was supported by data from a large, international program that included a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial. The trial evaluated the safety and efficacy of Botox vs. placebo in over 400 patients with lower limb spasticity following a stroke. Study data showed significant improvements in the 2 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). 

Botox has a plethora of indications, including: prophylaxis of headaches in adults with chronic migraine, severe primary axillary hyperhidrosis when topical agents are inadequate, cervical dystonia in patients ≥16yrs, reduces severity of abnormal head position and neck pain, strabismus or blepharospasm related to dystonia in patients ≥12yrs, and for adults who have an inadequate response to or are intolerant of an anticholinergic drug. It is available as 100U and 200U strength vials. 

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