Allergan Inc has started what it calls a human safety and efficacy study in India of Botox for treating neurogenic overactive bladder (NOAB), a urological disorder.
This chronic condition has symptoms of urinary urgency with or without incontinence; and affects millions of people worldwide, including in India. Medical experts say they have limited options for treating NOAB.
“Allergan is currently investigating the clinical safety and efficacy of Botox for NOAB in several countries throughout the world, including India,” said Crystal Cienfuegos, a spokesperson for Allergan.
Safety and efficacy studies in humans are conducted after testing for toxicity and dosage in early and midstage trials, known as phase I and II studies. These stages of Allergan’s urology trials were started in India early this year, but the results have not been made public.
According to Cienfuegos, independent investigators have studied and published reports about the safety and efficacy of Botox for NOAB and have demonstrated therapeutic improvements in patients with this disabling disorder in other regions.
Source: Livelink/Allergan