Botox, more famous for its wrinkle arresting feature, has been approved by the national regulator for treating headaches in adults with chronic migraine, according to Allergan, which makes and sells Botox.

Allergan India said chronic migraine is a severe neurological disorder suffered by patients who have a history of migraine and suffer from headaches for 15 or more days a month and the headache lasting four hours a day or longer.

US FDA approved

Botox (Botulinum toxin Type A), it said, was the first clinically-studied prophylactic treatment for such patients. The US FDA approved it last year and the national approval came three months back.

Botox, used by prescription, is already approved for other therapeutic uses such as for blepharospasm, cervical dystonia, hemifacial spasm and associated focal dystonias, spasticity, strokes and cerebral palsy, among children.

The product is derived from botulinum toxin protein from the bacterium, Clostridium botulinum.

Mr Raghu Kumar, Managing Director, Allergan India, told Business Line the company awaited approval in the US for some more indications, in particular for overactive bladder. That would be followed up in the domestic market, too.

Usage pattern

He said the cosmetic and medicinal businesses were evenly split in the country. Although Botox grew at 50-60 per cent a year, it was on a small base.

There were no clear market data or estimates on the aesthetic use pattern in the country – and which was less than in Taiwan or Singapore and not exploited fully.

“Globally, it is an above $1.5-billion brand for Allergan. But here in India, the eyecare range dominates. We would be generating awareness through campaigns and camps on the (aesthetic) benefits,” he said in a telephonic interaction.

According to the release, “Studies and clinical trials have revealed that when injected at labelled doses and in the recommended locations in the head and neck, Botox is expected to produce results lasting up to three months, depending on the patient.”

Mr Raghu Kumar said there were significant numbers of chronic migraine sufferers; neurologists reported 10-15 new patients every month. According to Dr R. Srinivasa, Senior Professor of Neurology and Head of the Department of Neurology, M.S. Ramaiah Medical College, Bangalore, Botulinum Toxin Type A was rapidly being considered by neurologists and pain specialists as a therapy for chronic migraine.

WHO ranks migraine as the 19th most disabling disease and an under-recognised neurological condition and notes that a day lived with severe migraine can be more disabling than blindness, paraplegia, angina (after walking 50 metres) or rheumatoid arthritis.

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