Spasticity, a condition in which certain muscles are continuously contracted, affects over 12 million worldwide. Generally, spasticity is associated with common neurological disorders like multiple sclerosis, stroke, cerebral palsy and spinal cord injury.Baclofen and Tizanidine are the drugs of choice. Baclofen is the largest prescribed drug for this indication, world wide.
Baclofen GRS uses a proprietary gastric release system which ensures longer retention in the stomach, hence increasing bioavailability. Baclofen GRS eliminates frequent day and night time dosing, and reduces the adverse effects from the peak concentration, specially sedative effects.
After extensive clinical trials, Baclofen ER capsules in six strengths are being marketed in India.
For the US, Phase III clinical trials will now be started for Spasticity, after intensive user surveys and specific protocol assessment with the USFDA.
One open label efficacy and safety study in alcohol dependence is planned in India, and regulatory approval for clinical trials is underway.