Rochester, NY 7/14/2009 11:27:12 PM
AVNR - AVANIR Pharmaceuticals Announces Open Label Extension Study of Zenvia
AVANIR Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc, AVNR
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AVANIR Pharmaceuticals, Inc. 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 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.
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