Phase 3 Study of Botox for Overactive Bladder
Allergan announced that two Phase 3 clinical trials of Botox (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase 3 clinical trials demonstrate that Botox significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment.
Both Phase 3 clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with Botox or placebo injections into the detrusor (bladder) muscle, followed by an injection with Botox after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with Botox vs. placebo (P<0.001).
Botox is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: treatment of leakage of urine (incontinence) in adults ≥18 years with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication; prevention of headaches in adults with chronic migraine who have ≥15 days each month with headache lasting ≥4 hours each day; treatment of increased muscle stiffness in elbow, wrist, and finger muscles in people ≥18 years with upper limb spasticity; treatment of the abnormal head position and neck pain that happens with cervical dystonia (CD) in people ≥16 years; treatment of the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people ≥18 years; and, treatment of certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people ≥12 years.
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