Synosia Starts Phase II Efficacy Trial For Rufinamide
The trial is an eight-week, double-blind, placebo-controlled, exploratory study being conducted in 20 sites in the United States. It will assess the efficacy and tolerability of rufinamide in up to 230 patients with general anxiety disorder, as measured by multiple psychometric assessment tools. Patients randomized to rufinamide will receive 250mg twice a day for one week followed by 500mg twice a day for seven weeks. The trial design was guided by the encouraging results of a proof-of-concept study announced in January 2008.
Rufinamide was discovered and developed by Novartis. Rights to SYN-111 were obtained by Synosia from Novartis in 2007 in an exclusive worldwide licensing agreement, outside of Japan, to develop and commercialize rufinamide for the treatment of anxiety and other mood disorders. Rufinamide is also marketed by Eisai in Europe as a drug to treat a form of epilepsy under the tradename Inovelon.
"Given the extensive safety experience available from previous studies, we believe this structurally novel compound has the potential to relieve anxiety without the adverse side effects of current treatments," said Stephen Bandak, Synosia's chief medical officer. "There is a real need for new treatment options without the limited compliance associated with selective serotonin reuptake inhibitors (SSRIs) or the risk of dependence of benzodiazepine-based treatments."
It is estimated that over 62 million people in the United States and the five major European pharmaceutical markets suffer from a form of anxiety. Of those, over nine million suffer from general anxiety disorder.