Rochester, NY 7/11/2009 2:29:45 AM
Afternoon Results - AVNR - AVANIR Pharmaceuticals Announces Zenvia Open Label Extension Study - Sourced WhisperFromWallStreet.com
Avanir Pharmaceuticals
Afternoon Results - AVNR - AVANIR Pharmaceuticals Announces Zenvia Open Label Extension Study - Sourced WhisperFromWallStreet.com
Avanir Pharmaceuticals, Inc,AVNR
1.85 Down 0.05 (2.63%) 3:11pm ET
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the open label extension of the confirmatory Phase III STAR trial is now fully enrolled. The primary objective of the open-label extension study is to assess the long-term safety of Zenvia (dextromethorphan/quinidine [DM/Q]) in patients diagnosed with pseudobulbar affect (PBA) resulting from an underlying neurological disorder. In total, 282 of 326 patients (or 86.5%) completed the 12-week double-blind phase of the study and were eligible to enroll in the open label extension phase. A total of 253 (or 89.7%) of eligible patients elected to enroll in the 12-week open label safety extension. The low overall rate of discontinuation in the blinded phase and high percentage of eligible patients choosing to enroll in the optional open label extension phase compare favorably with previous experience. "Completion of the blinded phase and full enrollment of the open label phase of the STAR trial are important milestones for AVANIR," said Dr. Randall Kaye, AVANIR's Chief Medical Officer. "We look forward to unblinding the top-line data in August 2009 and expect to have data from the open label extension available by the end of the year. With the complete data set from the STAR trial in hand, we plan to submit our full response to the approvable letter in the first half of 2010."
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ABOUT
Avanir Pharmaceuticals, a pharmaceutical company, focuses on developing, acquiring, and commercializing therapeutic products for the treatment of chronic diseases primarily in the United States. The companys product candidates address therapeutic markets that include the central nervous system and inflammatory diseases. Its lead product candidate Zenvia, a Phase III clinical development stage product for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic pain (DPN pain). The companys commercialized product, Abreva, an over-the-counter product for the treatment of cold sores, which is marketed by GlaxoSmithKline Consumer Healthcare in North America. Its inflammatory disease program, which targets macrophage migration inhibitory factor is partnered with Novartis International Pharmaceutical, Ltd. Avanir Pharmaceuticals was founded in 1988 and is headquartered in Aliso Viejo, California.
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