Mumbai: US drug firm Allergan Inc. has started a so-called human safety and efficacy study in India of Botox, a muscle relaxant as well as a cosmetic drug, for treating a urological disorder.
This health disorder, a chronic condition with symptoms of urinary urgency with or without incontinence, affects millions of people worldwide including in India. Medical experts say they have limited options for treating it at present.
Though the Indian urology and central nervous system drugs market is worth at least Rs1,600 crore, the market data for this particular segment is not available as it is a relatively new medical area.
Allergan had sought and got approval in 2007 for these clinical studies in India but had to wait to recruit patients for the trials. Botox, the largest revenue earner for Allergan with worldwide sales of $700 million (Rs3,507 crore), is currently approved for facial wrinkle treatment in the cosmetics space, and therapeutically for the treatment of certain neuromuscular disorders, in India.
“Allergan is currently investigating the clinical safety and efficacy of Botox for neurogenic overactive bladder (NOAB) in several countries throughout the world, including India,” said Crystal Cienfuegos, a spokesperson for Allergan, in an email response.
Safety and efficacy studies in humans are conducted after testing for toxicity and dosage in early and mid-stage 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 yet.
Allergan, which is conducting trials of Botox for urology as well as severe headaches in other countries, has not registered the urology study with India’s clinical trial registry yet. While listing a clinical study in the registry is not mandatory, it is important for making the public aware about the study and its progress.
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.
“Indian investigators are participating in two multinational studies that are currently enrolling patients with NOAB. We cannot comment on the progress of these studies, as they are still enrolling patients,” Cienfuegos said.
The company, which is currently facing a US department of justice, or DoJ, investigation against alleged off-label or unapproved use of Botox for the treatment of migraine, had in September announced that it has completed an analysis of its two human trials exploring the use of Botox for the prophylactic treatment of headache in adults suffering from chronic migraine that occur 15 or more days each month.
The company said it doesn’t currently have study sites in India for the headache programme.
In March, DoJ had issued a subpoena to Allergan for documents on marketing and educational activities involving Botox. The department is investigating the case.
“It is Allergan’s policy to promote its products only in a manner consistent with Food and Drug Adminstration-approved product labelling, and it is very unfortunate that Allergen’s marketing and promotional practices would be questioned,” the company said in a March statement after receiving the DoJ subpoena.