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Avera completes enrollment in social anxiety study

Avera Pharmaceuticals has completed enrollment in its phase II study of the Neurokinin-1 (NK-1) antagonist AV608 in subjects with social anxiety disorder.

This phase II, study in the US, investigating the safety and efficacy of AV608, has enrolled 182 subjects diagnosed with social anxiety disorder. The study was initiated in the first quarter of 2006 and preliminary results are expected in early 2007.

Following the acquisition of AV608 from Novartis in September 2003, Avera reformulated the compound to increase exposure after oral administration. This new formulation was successfully carried forward through phase 1 studies without dose-limiting toxicities and with good tolerability.

“Social anxiety disorder is a widely prevalent, chronic and highly disabling psychiatric disorder with limited treatment options. The brain circuits expressing the NK-1 receptors, which are thought to be important in mounting fear responses, appear to be overactive in patients with this disorder. Blockade of the NK-1 receptors may represent a new and rational approach to its treatment,” said Jeffrey McKelvy, President and Chief Technical Officer of Avera.