April 15, 2010 / 1:26 PM / in 7 years

UPDATE 1-Avanir says to file Zenvia response soon

2 Min Read

* Says no new safety concerns emerged from data

* To file full response with the FDA in next few weeks

* Expects approval decision by year-end * Shares up 7 pct before the bell

April 15 (Reuters) - Avanir Pharmaceuticals Inc AVNR.O said data from the late-stage trial of its neurological drug Zenvia showed no new safety concerns and it would file its full response with U.S. regulators within the next few weeks.

Shares of Avanir rose 7 percent to $3.33 in premarket trade on Thursday.

The late-stage STAR trial produced no reports of pro-arrhythmic events or cardiovascular serious adverse events for the drug, the company said in a statement.

Zenvia, which met the main goal of the STAR trial last August, was being studied as a treatment for pseudobulbar affect (PBA), a condition in which patients cannot control outbursts of crying or laughing. [ID:nBNG184283]

The company said it plans to file its full response with the U.S. Food and Drug Administration within the next few weeks and expects an approval decision on the PBA application before the end of the year.

Avanir said on Thursday the new lower dose formulations of Zenvia maintained statistically significant and clinically meaningful efficacy while providing an improved safety and tolerability profile relative to the original higher dose formulation. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Mike Miller)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below