Botox US bladder indication
pharmafile | January 22, 2013 | News story | Sales and Marketing | Allergan, Botox, FDA, bladder
Allergan’s Botox has been given approval by the FDA for the treatment of overactive bladder (OAB) in adults.
Botox (onabotulinumtoxinA) has demonstrated efficacy in reducing urinary leakage and will be indicated for patients who have an inadequate response to, or are intolerant of, an anticholinergic medicine.
The US regulator based its decision on two trials in this patient group in which Botox reduced daily urinary incontinence episodes by 50% or more after three months compared to placebo.
The injection calms muscle contractions temporarily by blocking the transmission of nerve impulses to the bladder muscle, thus relieving symptoms such as the uncontrolled urge to urinate or frequent urination.
“Allergan has a long-standing commitment to study the potential of Botox to treat a number of different medical conditions,” said Scott Whitcup, Allergan’s chief scientific officer.
“FDA approval is a milestone in the treatment of this burdensome condition and will provide a novel option for urologists and their OAB patients,” he added.
Anticholinergics are often prescribed in pill form but, Allergan says, more than half of patients are estimated to stop taking at least one within a year because of inadequate response or intolerance.
In the trials, around three times as many patients treated with Botox achieved complete elimination of their leakage episodes compared to placebo (22.9% and 31.4% of patients versus 6.5% and 10.3% at week 12).
While known primarily as a form of temporary cosmetic medicine popularised by celebrities to alleviate facial wrinkles, the brand in fact has 26 different indications.
These include to alleviate abnormal head position and neck pain with cervical dystonia, symptoms of severe primary axillary hyperhidrosis (underarm sweating) and the prophylactic treatment of headaches in adults with chronic migraine.
Adam Hill
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