AVANIR's Pivotal Neurodex Clinical Trial Data Presented at American Academy of Neurology Meeting; Data on the Treatment of PBA in MS Patients Selected as a ``Highlight of the Meeting''.SAN DIEGO -- AVANIR Pharmaceuticals (AMEX AMEX See: American Stock Exchange :AVN AVN Aviation AVN Avenue AVN Adult Video News AVN Avascular Necrosis AVN Atrioventricular Node AVN Aviation Model (weather forecast model, now Global Forecast System) AVN Air Vanuatu (ICAO code) ) announced that data 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 examining Neurodex(TM) in the treatment of pseudobulbar affect (PBA PBA Professional Bowlers Association PBA Palm Beach Atlantic University (West Palm Beach, Florida) PBA Partial-Birth Abortion PBA Philippine Basketball Association PBA Public Broadcasting Atlanta (Georgia, USA) ) in patients with multiple sclerosis (MS) were presented today at the 2005 Annual Meeting of the American Academy of Neurology The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 by A.B. Baker of the University of Minnesota to advance the art and science of neurology, and thereby promote the best (AAN AAN American Association of Neurology ) in Miami, Florida. Dr. Hillel Panitch, Professor of Neurology at the University of Vermont College of Medicine and Director of the Multiple Sclerosis Center at Fletcher Allen Health Care Fletcher Allen Health Care is a tertiary referral hospital for Vermont and northern New York State, a Level I Trauma Center, and a teaching hospital in alliance with the University of Vermont College of Medicine. in Burlington, Vermont, presented the results of the trial. Additionally, a summary of the data has been selected for presentation at the AAN's "Scientific Program Highlights Plenary Session" on Friday, April 15th at 5:15 pm. "Neurodex is the first drug designed specifically to treat PBA," reported Dr. Panitch, one of the 22 investigators who participated in the trial. "The only treatment option available to patients now is antidepressants, which can have a number of undesirable side effects. Based on the study data, patients enrolled in the trial showed improvement as early as the first week after starting treatment." In the double-blind study, 150 MS patients with PBA were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive either placebo or Neurodex on a 12 hour dosing schedule for 90 days. In his presentation, Dr. Panitch stated that 84% of patients treated with Neurodex reported that their condition improved, compared to 49% of those given a placebo. The study participants kept a diary tracking the number of laughing/crying episodes they experienced each day. Dr. Panitch noted that Neurodex-treated patients reported 46% fewer laughing and/or crying episodes than those on placebo during the three-month trial. Neurodex-treated patients also reported overall improvement in their quality of life, quality of relationships, and in the amount of pain they experienced. Of the side effects reported in 5% or more of the patients, a statistically significant difference between Neurodex and placebo was observed only for dizziness. In the Neurodex group, 14% of patients withdrew from therapy due to adverse events, compared to 11% discontinuing in the placebo group. The majority of reported side effects were mild to moderate in intensity. Pseudobulbar affect is a disinhibition dis·in·hi·bi·tion n. 1. A loss of inhibition, as through the influence of drugs or alcohol. 2. A temporary loss of an inhibition caused by an unrelated stimulus, such as a loud noise. syndrome of the motor expression of emotion and is characterized by uncontrollable laughing or crying in a manner that is out of context to the basic social setting. PBA affects patients with neurological conditions such as ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. or Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. , Alzheimer's disease, MS, stroke and 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 . AVANIR is currently developing Neurodex(TM) for the treatment of two different indications, PBA and diabetic neuropathic pain. AVANIR has completed Phase III clinical testing of Neurodex for the treatment of PBA, and began submission of a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for this indication to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in December 2004. The submission is being done on a "rolling" basis, which allows AVANIR to submit the NDA in modules that can be evaluated by the FDA as they are submitted. The NDA will receive priority review upon completion of submission. If approved, Neurodex would be the first drug indicated to treat PBA. In a market survey commissioned by AVANIR, IMS Health estimated the potential market for drugs that treat PBA to be approximately $500 million in 2006, the year in which Neurodex may enter the market if approved by the FDA. Beginning in mid-2005, AVANIR intends to conduct a Phase III clinical trial for the treatment of diabetic neuropathic pain under a Special Protocol Assessment from the FDA. AVANIR Pharmaceuticals is a drug discovery and development company focused on developing and commercializing novel therapeutic products for the treatment of chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com. AVANIR press releases and presentations, including any forward-looking statements contained therein, should be reviewed in conjunction with the Company's most recent Annual Report on Form 10-K, subsequent quarterly reports on Form 10-Q 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 as "estimate," "anticipate," "intend," "plan" or "expect" and actual results may differ from these forward looking statements. The Company can make no assurances regarding the timing of completion of its rolling submission of a new drug application for Neurodex(TM), whether the FDA will accept the Company's new drug application for Neurodex or whether the FDA will ultimately approve Neurodex for commercialization. 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. Even if Neurodex is approved for commercialization, the Company can make no assurances that it, or any of its marketing partners, will be able to successfully commercialize Neurodex. The Company disclaims any intent or obligation to update these forward-looking statements. |
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