AVANIR to Hold Conference Call to Discuss Positive Results from Phase III Clinical Trial of Neurodex for Pseudobulbar Affect
Call Scheduled for 4:30 PM ET TodaySAN DIEGO--(BUSINESS WIRE)--Aug. 24, 2004-- AVANIR Pharmaceuticals (AMEX:AVN) will hold a conference today at 4:30 pm Eastern to discuss the results of the Company's second Phase III trial of Neurodex. The Company announced positive pivotal Phase III clinical trial results this morning evaluating the safety and effectiveness of Neurodex(TM) for the treatment of pseudobulbar affect (PBA) in patients with multiple sclerosis (MS).
The call will be web cast live through AVANIR's corporate web site at http://www.avanir.com/. The dial in number for U.S. callers is 866-219-5256; international callers please dial 703-639-1119. For those who cannot listen to the live broadcast, the online replay will be available for 90 days, and a phone replay will be available through August 31, 2004, by dialing 888-266-2081 (domestic) and 703-925-2533 (international) and entering the passcode 546536.
Neurodex is a patented, orally administered combination of dextromethorphan and an enzyme inhibitor, quinidine, which sustains elevated levels of dextromethorphan in the human body. Results of Phase I studies have demonstrated that the combination of dextromethorphan and a low dose of quinidine results in elevated and prolonged dextromethorphan blood levels (Clinical Pharmacology & Therapeutics, 1992; 51: 647-55; 1999; 39: 984). Dextromethorphan has activity as both a sigma-1 receptor agonist and an NMDA receptor antagonist.
Neurodex is the first drug product in clinical development specifically intended to treat PBA. The first Phase III trial of Neurodex for PBA in ALS patients was completed in June 2002. The double blind, controlled, multicenter clinical trial had three treatment arms and compared Neurodex to each of its two components, dextromethorphan and quinidine. With statistically significant data achieved in two patient populations, patients with ALS and patients with MS, AVANIR intends to seek an indication to treat PBA associated with any neurological condition.
AVANIR Pharmaceuticals is a drug discovery and development company focused on novel treatments for chronic diseases. The company's most advanced product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect, and in Phase II clinical development for neuropathic pain. A potential treatment for allergy and asthma, AVP 13358, is in Phase I clinical development. 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 submission of a new drug application for Neurodex, 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.
CONTACT: AVANIR Pharmaceuticals
Patrice Saxon, 858-622-5202
SOURCE: AVANIR Pharmaceuticals