
Because of its benefit for RLS (Restless leg syndrome) and the association of RLS with fibromyalgia syndrome (FMS), dopamine agonists are considered a new treatment option for FMS, a condition affecting 6-12 million Americans and 2-4% of the world's population. Pfizer received the first US FDA approval for a fibromyalgia pharmaceutical (Lyrica) on June 21, 2007.
Ropinirole is a second generation dopamine agonist and one of two discovered dopamine 2/3 receptor agonists commonly used to treat Parkinson's disease and Restless Leg Syndrome. It has no effect on beta-adrenergic, serotonin, norepinepherine, muscarinic, opioid, GABA, dopamine (1,4,5), benzodiazepine or other CNS receptors. Because of its uniquely specific mechanism of action, important conclusions can be drawn from observation of its clinical effect in patients with fibromyalgia.
Ropinirole was developed by GSK and FDA approved for treatment of Parkinson's disease in 1997 and for restless leg syndrome in 2005.
Ropinirole is well tolerated even in a high-risk elderly populations with Parkinson's disease.
Phase I completed.
Investigational treatment of FMS with ropinirole was first reported in 2003 in the Journal of Clinical Rheumatology, and a pilot randomized, placebo controlled trial was reported at the annual meetings of the American College of Rheumatology and ritish Society for Rheumatology.
Inmedix's US ropinirole patent for a fibromyalgia indication was granted in 2001. GSK holds the compound patent for ropinirole, which will expire on May 19, 2008.
Inmedix is seeking a partner who offers development, reformulation and/or marketing expertise. The end goal is to bring the drug to market, capture double-digit market share and help many of the 12 million people who suffer from fibromyalgia.