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news.Avanir Pharmaceuticals has reached a definitive agreement with the FDA, under the special protocol assessment process, on the design of a Phase III clinical trial of Zenvia for the treatment of patients with pseudobulbar affect.
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The trial, which is aimed at determining the pharmacokinetics of two doses of Zenvia (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA) in patients with amyotrophic lateral sclerosis and multiple sclerosis (also know as Star trial) is expected to begin enrolling patients by the end of 2007.
Pseudobulbar affect, also known as involuntary emotional expression disorder and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays.
Randall Kaye, chief medical officer, said: “We now have a clear path toward gaining regulatory approval for Zenvia in this important indication and continue on track to begin patient enrollment in this trial before 2007 calendar year end. We have developed an alternative formulation of Zenvia with a lower dose of the quinidine component than the formulation used in earlier PBA studies.
“Based on our extensive PK/PD modeling, we expect that the new formulation of Zenvia will demonstrate acceptable safety and tolerability, while continuing to provide significant efficacy.”