Avanir’s Zenvia Set Back Two Years, But Path Forward Is Established With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will undertake a new low-dose trial of the involuntary emotional expression disorder treatment to address cardiovascular risks, including QT prolongation.
You may also be interested in...
Avanir's Struggle Was Worth It: Reformulated Zenvia Succeeds In Confirmatory Phase III
Once crushed by an FDA approvable letter for the emotional outburst therapy, the company has battled to stay afloat and now anticipates launching the drug in the second half of 2010.
Avanir's Struggle Was Worth It: Reformulated Zenvia Succeeds In Confirmatory Phase III
Once crushed by an FDA approvable letter for the emotional outburst therapy, the company has battled to stay afloat and now anticipates launching the drug in the second half of 2010.
Avanir's Reformulated Zenvia Succeeds In Confirmatory Phase III
After battling back from a crippling FDA "approvable" letter for Zenvia, its investigational treatment for the sudden and unpredictable emotional outbursts that can accompany neurologic diseases, Avanir is buoyantly predicting a 2010 launch based on positive top-line data from the Phase III confirmatory study it conducted at the agency’s behest.