Synosia completes proof-of-concept rufinamide trial

USA-based Synosia Therapeutics, a privately-owned drug development company, has completed the first clinical trial of the sodium channel blocker SYN-111 (rufinamide) in mood disorders. The drug, which was developed by Novartis, is currently sold as Inovelon in Europe for the treatment of epilepsy by Japanese drugmaker Eisai under a licensing agreement established in 2004 (Marketletters passim).

Synosia, which signed a deal to develop rufinamide for anxiety and bipolar mood disorders last year (Marketletter May 7, 2007), explained that the placebo-controlled, three-dose study was designed to measure the drug's effect on brain wave response patterns in healthy volunteers. Over a 24-hour period, electroencephalography was able to detect quantitative changes stimulated by the drug, indicating potential therapeutic activity.

Synosia chief medical officer Stephen Bandak, commented that "the data from this study lend support to observations in animal behavior models and further justify investigation of the effect of rufinamide for mood disorders." He added that the work had helped establish the most appropriate dose for examination in Phase II trials, which are expected to start later in the year.