logo
  Join        Login             Stock Quote

Teva Pharmaceutical (TEVA): Armodafinil Drug Fails To Meet Endpoints In Bipolar Depression Trial

 January 23, 2013 12:09 PM
 


(By Balaseshan) Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) said its second study for armodafinil (Nuvigil) failed to demonstrate efficacy in meeting primary and secondary endpoints as adjunct therapy in adults with major depression associated with bipolar 1 disorder.

While study 3072 of Phase 3 clinical program demonstrated a numerical improvement, armodafinil treatment, at a dosage of 150 mg per day, failed to be more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics, Teva said.

This is the second of three, Phase 3 studies; results of the first pivotal study 3071 announced in May, 2012 were positive. Study 3073 and open-label extension study 3074 are ongoing; results are expected for study 3073 later this year.

[Related -Invest In Stocks With A Margin Of Safety To Reduce Risk And Enhance Returns]

In controlled trials in adults administered Nuvigil, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. The most common adverse events in controlled clinical trials (5% or greater) were headache, nausea, dizziness, and insomnia.

"We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease," said Michael Hayden, president of Global R&D and Chief Scientific Officer.

[Related -Teva Pharmaceutical (TEVA) Dividend Stock Analysis]

Armodafinil is currently sold under the brand name Nuvigil, which is a prescription medicine indicated to improve wakefulness in adults who experience excessive sleepiness (ES) due to obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.

Bipolar 1 disorder is defined by manic or mixed episodes that last at least a week in which an individual feels abnormally euphoric, optimistic, and energetic, and can be so severe as to require hospitalization, followed by depressive episodes typically lasting at least two weeks.

TEVA is trading up 0.03% at $37.92 on Wednesday. The stock has been trading between $36.63 and $46.65 for the past 52 weeks.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageXerox Corp. (XRX): An Insider’s $500,000 Insider Buy

Last week was a healthy week of insider buying as 194 companies reported purchase records. The number read on...

article imageQihoo 360 Technology Co Ltd. (QIHU) Q2 Earnings Preview: A Green Monday

Qihoo 360 Technology Co Ltd. (NYSE:QIHU) will report its second quarter 2014 financial results on Monday, read on...

article imageSix Stocks that Could Outperform in the next 90 days

Earlier today, Goldman Sachs put out its list of the 50 stocks that Matter Most. It’s a list of the 50 read on...

article imageFoot Locker, Inc. (FL) Q2 Earnings Preview: Running Past the Street View

Foot Locker, Inc. (NYSE:FL) plans to report financial results for its second quarter ended August 2, 2014 read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.