Today, more than 20 million people in the US suffer from musculoskeletal conditions. There are approximately 60 million total prescriptions written annually by physicians in the US, with cyclobenzaprine (Flexeril®)established as the leading prescribed product in this product category, with a 40% market share.
Common to all currently marketed products in this category including cyclobenzaprine are limitations on usage associated with sedation, resulting in a costly impact on patient functionality and work/life productivity. Market research indicates that both patients and physicians would be strongly supportive of tolperisone if it is shown to be non-sedating in clinical studies. Tolperisone is non-abusable, non-scheduled and is not an opioid. This further differentiates it from competing products, some of which have the potential for abuse.
At the time of launch, tolperisone is expected to be the only non-sedative product in the therapeutic category.