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09-17-2003, 12:49 AM
AVANIR Pharmaceuticals, (AMEX: AVN) will feature its lead neurology product candidate Neurodex™ in a presentation at ThinkEquity Partners Growth Conference in San Francisco today. Neurodex is in Phase III clinical development for the treatment of pseudobulbar affect (PBA) and in Phase II clinical development for neuropathic pain. Neurodex is a novel product utilizing the known drug dextromethorphan in a patented delivery system.
Neurodex is the first drug candidate in clinical development specifically intended to treat PBA. The condition, also know as emotional lability, is characterized by episodes of inappropriate laughing or crying. It afflicts up to a million people in the U.S. with underlying neurodegenerative diseases such as Alzheimer's, multiple sclerosis, Lou Gehrig's disease or ALS, Parkinson's, traumatic brain injury and stroke. The company completed a pivotal Phase III study in ALS patients with PBA in which Neurodex showed highly statistically significant results for its primary endpoint (p less than 0.0013) and met all secondary endpoints. AVANIR is currently enrolling multiple sclerosis patients in a final Phase III study and anticipates submitting an NDA in 2004.
"The results of our clinical trials to date suggest that Neurodex is well positioned to fit unmet market needs in the treatment of both PBA and neuropathic pain," said President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "Both treatment areas are growing and physician and patient satisfaction with currently available products is modest at best."
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Neurodex is the first drug candidate in clinical development specifically intended to treat PBA. The condition, also know as emotional lability, is characterized by episodes of inappropriate laughing or crying. It afflicts up to a million people in the U.S. with underlying neurodegenerative diseases such as Alzheimer's, multiple sclerosis, Lou Gehrig's disease or ALS, Parkinson's, traumatic brain injury and stroke. The company completed a pivotal Phase III study in ALS patients with PBA in which Neurodex showed highly statistically significant results for its primary endpoint (p less than 0.0013) and met all secondary endpoints. AVANIR is currently enrolling multiple sclerosis patients in a final Phase III study and anticipates submitting an NDA in 2004.
"The results of our clinical trials to date suggest that Neurodex is well positioned to fit unmet market needs in the treatment of both PBA and neuropathic pain," said President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "Both treatment areas are growing and physician and patient satisfaction with currently available products is modest at best."
READ FULL ARTICLE: http://home.businesswire.com/portal/site/g...ws_process_view (http://home.businesswire.com/portal/site/google/index.jsp?epi-content=GENERIC&epi-process=generic_process.jsp&newsId=20030916005789&headlineSearchConfigBO=1063742400000%2010637588510 00%20%20groupByDate%20%201%20-4%201063742400000%20%20%20%20%20%20%20%20%20100015 1%20false%20true%20&newsPopup=false&newsLang=en&beanID=478837757&viewID=news_process_view)