This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

MDD Fact Sheet

Forest Laboratories, Inc. (NYSE:FRX) announced today that FETZIMA™ (levomilnacipran ER capsules), is now available in pharmacies throughout the United States. FETZIMA was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD), also known as depression, in adults in July 2013.

“We are pleased to announce that FETZIMA is now available to patients,” said Dr. Marco Taglietti, Executive Vice President, Drug Development & Research and Chief Medical Officer. “Despite the number of available antidepressant medications, the treatment of depression remains a clinical challenge with a need for additional treatment options. In clinical studies, patients who received FETZIMA vs. placebo experienced meaningful improvement in their depressive symptoms and functional impairment. The availability of FETZIMA is a significant step forward in our goal of bringing a range of treatment options to adults living with MDD.”

FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI). The efficacy of FETZIMA was established in three positive double-blind Phase III studies comprising two fixed-dose studies and one flexible-dose study that compared FETZIMA to placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either FETZIMA (40, 80, 120 mg) or placebo in the three studies. In all three studies, significant improvement in depressive symptoms was demonstrated across 3 FETZIMA dosage strengths (40, 80, and 120 mg) once daily, as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, physician-rated scale for assessing the severity of depressive symptoms. Each of the 10 symptoms is rated on a scale of 0-6; higher numbers denote greater severity of symptoms.

For study 1, the mean baseline MADRS total score was 36 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at all three FETZIMA doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2, the mean baseline MADRS total score was 31 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at both FETZIMA doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total score was 35 for both treatment groups. The LS mean difference from placebo in change from baseline was statistically significant for the FETZIMA dosing range studied (-3.1 at 40-120 mg/day).

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs