FDA Approves New Treatment for Lower Limb Spasticity in Adults

The FDA has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult to decrease the severity of increased muscle stiffness in ankle muscles and toe muscles.

Approval was based on an international development program that included a phase III, multicenter, double-blind, randomized, placebo-controlled clinical trial that evaluated more than 400 patients with lower limb spasticity following stroke.

A total onabotulinumtoxinA dose of 300 to 400 units divided among ankle and toe muscles (n=233) was compared to placebo (n=235). Statistically significant improvements were observed in the 2 co-primary endpoints of average change from baseline in the improvement of muscle tone measured and the clinical benefit for patients at weeks 4 and 6 (P<0.05).

Adverse reactions included arthralgia, back pain, myalgia, upper respiratory tract infection, and injection site pain.

OnabotulinumtoxinA is a prescription medicine indicated for the treatment of increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity.

For complete product information, visit https://www.allergan.com/assets/pdf/botox_pi.pdf.