Forest Laboratories, Inc.
) announced positive top-line results from three phase III trials
evaluating the efficacy, safety and tolerability of Viibryd in
adults suffering from generalized anxiety disorder (GAD). The three
phase III studies were - MD-07, MD-06 and MD-05. While MD-07 and
MD-06 compared the use of a flexible dose of Viibryd (20-40mg/day)
to placebo, MD-05 evaluated a fixed dose of Viibryd (20 or 40
The primary endpoint of the trials was the change from baseline to
the end of week 8 in the Hamilton Rating Scale for Anxiety (HAM-A)
total score. In the MD-07 and MD-06 trials, Viibryd (20-40mg/day)
demonstrated statistically significant improvement in the HAM-A
total score as compared to placebo. In MD-05, statistically
significant improvement in the HAM-A total score was observed in
the Viibryd 40 mg/day arm as compared to the placebo arm.
Based on the encouraging results, Forest Labs plans to submit a
supplemental New Drug Application for Viibryd for the GAD
indication to the FDA next year.
We note that Viibryd is already approved by the FDA for the
treatment of adults with major depressive disorder. The drug
generated revenues of $52.8 million in the fourth quarter of fiscal
2014, representing an increase of 18.4% over the year-ago period.
Forest Labs is looking to expand Viibryd's label to boost product
We remind investors that Forest Labs is set to be acquired by
) later this year for a cash and equity transaction valued at about
$25 billion. Once the deal closes, Forest's shareholders will own
35% of the new company
Forest Labs carries a Zacks Rank #2 (Buy). Other well-ranked stocks
in the health care sector include
Regeneron Pharmaceuticals, Inc.
). Both Allergan and Regeneron hold a Zacks Rank #1 (Strong
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