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For more details, a PDF version of each poster can be found at the Company's website (www.avanir.com).
About Diabetic Neuropathic Pain
Diabetic neuropathic pain, one of the most debilitating forms of pain, is caused by nerve damage that can result from diabetes. It is often described as burning, tingling, stabbing, or pins and needles in the feet, legs, hands or arms. An estimated 3.5 million people in the United States experience diabetic neuropathic pain according to the American Diabetes Association.
About Zenvia
Zenvia is a combination of two well-characterized compounds, the therapeutically active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways, through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of Involuntary Emotional Expression Disorder (IEED) and DPN pain.
In October 2006, the Company received an approvable letter for
the treatment of Zenvia in IEED. To address safety concerns raised
in the FDA's approvable letter for Zenvia for the treatment of
IEED, the company intends to initiate a confirmatory Phase III
study with a new lower quinidine dose formulation of Zenvia. In
April 2007 AVANIR completed a Phase III study in patients with
diabetic peripheral neuropathic pain where all primary endpoints
were successfully met.
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