The US drug major Allergan today announced that the Drugs Controller General of India (DCGI) has granted approval to Botox, (Botulinum Toxin Type A) for treating paediatric spasticity due to Cerebral Palsy (CP), in India.

CP is caused due to lesion in the brain before or during birth. One of the manifestations of CP is spasticity (increased muscle tone), which hampers normal growth of the skeletal muscle in children. This results in poor gait and posture due to lack of harmony between bone and muscle growth and joint instability. Globally, India becomes the 44th country for Allergan, with regulatory approval for Botox for paediatric spasticity due to CP.

Data from several large clinical trials worldwide has demonstrated that Botox is highly effective in acting locally on affected muscles and improving movement. It has been established as a critical part of an integrated approach to managing children with CP.

Botox acts by preventing the transmission of signals between a nerve and it's target muscle. This blocking action allows the reduction of the excessive stiffness in the muscle and allows the muscles to grow normally. Depending on the severity of spasticity, Botox procedure can eliminate the need for surgery or less extensive surgery with fewer operations.

According to K B R Menon, managing director, Allergan India, " Botox is currently a US$ 320 million brand worldwide, with approved usage for blepharospasm, hemifacialspasm, focal dystonias, hyper hydrosis and treatment of glabellar lines. The approval of Botox for paediatric spasticity due to CP, has added a new dimension to our business, and we believe that this approval will be of great value to Indian practitioners and patients. Botox provides tremendous quality of life improvements to selected patients with CP. We will continue to develop the market through collaborative efforts with our prescribers and invest in educative campaigns for the benefit of parents and carers."

Botox is prescribed for management of dynamic muscle contractions in early stages of spasticity. Leading experts in the field of paediatric spasticity, Dr. A N Johari, orthopaedic surgeon from Bombay Hospital and Dr. GP Dureja from the All India Institute of Medical Sciences (AIIMS), in-charge of Pain Clinic and Department of Anaesthisiology welcomed the DCGI's decision.

Outlining the incidence of CP in India, the experts said, "CP is the commonest cause of physical handicap and the prevalence amongst children is 1 in 400 live births. Once the functional deficits in the affected child are clearly identified and goals of treatment defined, Botox procedure must be used as an adjunct to conventional treatments including physiotherapy and medication."

The price of the Botox is approximately Rs. 15,000 for a vial of 100 units.

Allergan's Botox is the only one of its type with over 10 years of successful clinical experience in therapeutic conditions. In 1989, Botox therapy was approved in the U.S. for the treatment of strabismus and blepharospasm and, in December 2000, for the treatment of abnormal head position and neck pain associated with cervical dystonia. Botox therapy is approved in 70 countries for a broad range of conditions, and is currently being investigated in the U.S. for the treatment of many different medical conditions including hyperhidrosis (excessive sweating), post-stroke spasticity, back spasm and headache.

In India, Botox is approved for neurological conditions, such as blepherospasm, hemifacial spasm and neck dystonia and now paediatric spasticity due to Cerebral Palsy.

Several scientific papers have been published, documenting the effectiveness of treatment of pediatric spasticity due to Cerebral Palsy with Botulinum Toxin Type A in many reputed journals such as the European Journal of Neurology, Muscle and Nerve, Developmental Medicine and Child Neurology etc.