AVANIR Presenting Neurodex Data at International Symposium On ALS/MND.Business Editors/Health/Medical Writers 14th International Symposium on ALS/MND BIOWIRE2K SAN DIEGO--(BUSINESS WIRE)--Nov. 17, 2003 AVANIR Pharmaceuticals (AMEX AMEX See: American Stock Exchange : AVN) announced today that data collected from its Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of Neurodex(TM) in the treatment of pseudobulbar affect in patients with amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, (ALS) will be presented at the 14th International Symposium on ALS/MND being held in Milan, Italy, November 17 - 19, 2003. Presenting the poster, Distinguishing Affective Disorders in Amyotrophic Lateral Sclerosis, will be the drug's inventor, Richard A. Smith, M.D., a Skaggs Clinical Scholar at Scripps Research Institute in La Jolla, Calif., and founder of the Center for Neurologic Study. AVANIR's lead product, Neurodex, is a late stage, first-in-class drug candidate for pseudobulbar affect (PBA), a central nervous system disorder. Neurodex is in Phase III clinical development for the treatment of PBA in neurodegenerative diseases including Alzheimer's, multiple sclerosis, Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. or ALS, Parkinson's, traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain and stroke. PBA, also know as emotional lability lability /la·bil·i·ty/ (lah-bil´i-te) 1. the quality of being labile. 2. in psychiatry, emotional instability. lability the quality of being labile. , is a symptom of neurodegenerative diseases that manifests itself in abrupt, inappropriate or excessive displays of tearfulness or laughter. Motor neuron disease motor neuron disease: see amyotrophic lateral sclerosis. (MND) is the name given to a group of related diseases affecting the motor neurons, or nerve cells, in the brain and spinal cord. In neurodegenerative diseases, the motor neurons gradually die and muscles stop functioning. MND was first described in 1874 by French neurologist Jean-Marie Charcot. In the U.S. and other countries, it is known as ALS or amyotrophic lateral sclerosis. The Motor Neurone Disease Association The Motor Neurone Disease Association (MND Association) is a British charity established in 1979 by a group of volunteers to coordinate care, support, and research for people affected by motor neurone disease (also known as amyotrophic lateral sclerosis or Lou Gehrig's disease). was established in 1979 and aims to ensure people affected by MND can secure the care and support they need, while promoting research into causes and treatments. The International Symposium on ALS/MND is an annual event that brings together leading international researchers and health and social care professionals to present and debate key innovations in their respective fields. AVANIR Pharmaceuticals is a drug discovery and development company focused on the development of treatments for central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency and inflammatory diseases. The company's first commercialized FDA-approved product, Abreva(R), is marketed in North America by GlaxoSmithKline and is the leading over-the-counter product for the treatment of cold sores. The company's lead product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect and in Phase II clinical development for neuropathic pain. An internally developed small molecule, AVP 13358, is in a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for the treatment of allergy and asthma. Using its proprietary Xenerex(TM) technology, AVANIR also develops human monoclonal antibodies for infectious diseases and other therapeutic applications. Further information about AVANIR can be found at www.avanir.com. The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect." Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the company. |
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