Forest Laboratories Announces Positive Phase III Study Results for Nebivolol and Valsartan Combination in Hypertension
June 27 2013 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) today announced positive
topline results from an 8-week pivotal Phase III clinical trial
evaluating the efficacy and safety of investigational fixed dose
combination (FDC) of nebivolol and valsartan for the treatment of
hypertension.
The combination of nebivolol and valsartan demonstrated
statistically significant reductions in diastolic blood pressure
(DBP) vs. both nebivolol alone and valsartan alone at 8 weeks,
which was the primary endpoint. The FDC also met the key secondary
endpoint of change from baseline in systolic blood pressure (SBP)
at 8 weeks.
The single pivotal nebivolol/valsartan FDC trial was designed to
meet the required regulatory “Combination Rule,” comparing a FDC
against the highest approved dose of each component drug.
“These Phase III results in patients with Stage 1 or Stage 2
hypertension are exciting and demonstrate the potential benefits of
this novel FDC -- a first-in-class beta blocker/ARB combination,”
said Marco Taglietti, MD, Senior Vice President of Research and
Development and President, Forest Research Institute. “We are very
pleased with these results which demonstrate the efficacy and
safety profile of this combination and support the potential use of
the nebivolol/valsartan FDC as a new treatment option for patients
with hypertension who need dual therapy to reach their blood
pressure goals.”
Based on these positive results, Forest plans to submit a
regulatory filing with the Food and Drug Administration (FDA) in
the first quarter of calendar year 2014.
About the Phase III Study
This pivotal 8-week randomized, double-blind, placebo-controlled
clinical trial in 4,161 hypertension patients studied nebivolol 5,
10, 20, and 40mg and valsartan 80, 160, and 320mg alone and in
fixed dose combinations.
The study consisted of a 1-week screening period, followed by 6
weeks of placebo wash-out, an 8-week double-blind treatment period,
and a 1-week down-titration period. During the double-blind
treatment period, patients were initially randomized to one of
eight treatment groups: FDC nebivolol/valsartan 5/80, 5/160, or
10/160mg; nebivolol 5 or 20mg; valsartan 80 or 160mg or placebo.
After four weeks, all dosages were doubled.
The primary endpoint was change from baseline in mean sitting
trough DBP at 8 weeks for FDC dose 20/320mg versus nebivolol 40mg
(the highest approved nebivolol dose) and versus valsartan 320mg
(the highest approved valsartan dose), and FDC doses 10/320mg and
10/160mg versus corresponding monotherapies. Across these doses,
the incremental reduction in DBP for the combination vs. nebivolol
was -1.2 to -2.4 mm Hg; (p value 0.03 to
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