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Avera Pharmaceuticals
completes enrollment in Phase 2 Social Anxiety Disorder Study
SAN
DIEGO - September 25, 2006
Avera Pharmaceuticals, Inc., announced today it has completed enrollment in its ongoing Phase 2 study of the Neurokinin-1 (NK-1) antagonist AV608 in subjects with social anxiety disorder (also called social phobia).
This Phase 2, double-blind, placebo-controlled, 12-week, multi-center study in the United States, 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.
"Completion of enrollment in this trial represents a significant milestone for Avera,"said Jeffrey McKelvy, President and Chief Technical Officer of Avera. "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."
About AV608
Following the acquisition of AV608 from Novartis in September 2003, Avera reformulated the compound to increase exposure after oral administration. This novel formulation was successfully carried forward through Phase 1 studies without dose-limiting toxicities and with good tolerability.
Avera also initiated proof-of-concept evaluations with AV608 in irritable bowel syndrome and overactive bladder during the second quarter of 2006. These studies are currently enrolling patients.
Avera
Pharmaceuticals, Inc.
Avera Pharmaceuticals, Inc. (San Diego, CA) is a privately held, specialty pharmaceutical
company focused on developing and commercializing novel compounds in the neuroscience therapeutics
arena. The Company's strategy is to identify opportunities for therapeutic advances in the treatment
of neurologic and psychiatric disorders, and then to in-license, develop and commercialize promising
compounds that can meet these needs. The company has three potential products in clinical development
that include compounds licensed from Novartis, Eli Lilly and GlaxoSmithKline. Additional information
on the Company can be found at www.averapharm.com.
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