Forest Laboratories, Inc. (FRX) 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 mg/day).
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 revenues.
We remind investors that Forest Labs is set to be acquired by Actavis (ACT) 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 Allergan (AGN) and Regeneron Pharmaceuticals, Inc. (REGN). Both Allergan and Regeneron hold a Zacks Rank #1 (Strong Buy).
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