* FDA sets Oct. 30 as action date for Zenvia review
* Avanir shares up 6 pct in pre-mkt trade
May 17 Avanir Pharmaceuticals Inc AVNR.O said
the U.S. health regulator accepted the resubmission on its
experimental treatment for a neurologic condition and will
review the application within six months.
The U.S. Food and Drug Administration set an action date of
Oct. 30 on the drug Zenvia, the company said in a statement.
Zenvia aims to treat pseudobulbar affect (PBA), a
neurologic condition characterized by involuntary, sudden, and
frequent episodes of laughing and/or crying in patients with
certain underlying neurologic diseases or injuries.
PBA affects an estimated two million Americans with
multiple sclerosis, Lou Gehrig's disease, stroke and other
neurological diseases or trauma that can cause brain lesions.
The company had faced a setback on the drug in October 2006
when the FDA sent it a so-called approvable letter and asked
for additional trial data.
Avanir expects an FDA approval decision in the fourth
quarter of 2010.
Shares of the company were up 6 percent to $2.85 in
pre-market trade. They closed at $2.69 Friday on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Prem