NEW YORK, Sept. 4 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) announced the results of a controlled clinical trial, published in the September 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol, a selective beta 1-blocker with vasodilating properties, significantly reduced sitting diastolic and systolic blood pressure among patients with mild-to-moderate hypertension. The study - the first to evaluate the drug in a U.S. population - also found that nebivolol was well tolerated in comparison to placebo and was not associated with adverse changes in blood glucose levels. Nebivolol is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension.
"Next-generation beta blockers, such as nebivolol, represent a step forward in the treatment of hypertension," said Robert J. Weiss, M.D., Director Cardiovascular Research, Maine Clinical Research. "As we saw in the study, nebivolol demonstrated efficacy with a low incidence of side effects typical of traditional beta blockers, such as fatigue, erectile dysfunction, and depression. In addition, there were no clinically significant changes in glucose levels, which makes nebivolol useful in patients with certain metabolic disorders."
In the double-blind, placebo-controlled study, a total of 909 patients were randomized to receive placebo (81 patients) or nebivolol (828 patients) dosed at 1.25mg, 2.5mg, 5mg, 10mg, 20mg or 40mg once daily for up to 12 weeks. The 40mg dose was included to study safety only. The study concluded that nebivolol, at doses of 1.25mg to 20mg once daily, significantly reduced both trough sitting diastolic and systolic blood pressure. Additionally, the study demonstrated that nebivolol was well tolerated by comparison to placebo treatment. Headache was the most common treatment-related adverse event experienced by 7.1% of the pooled nebivolol-treated patients (dosages of 1.25mg to 40mg once daily) and 7.4% of the placebo-treated patients. Of note, in the pooled nebivolol group, the incidence of AEs commonly associated with traditional beta blocker use, including fatigue (3.6% vs. 2.5% with placebo), erectile dysfunction (0.2%), and depression (0.2%) was low. Moreover, nebivolol was not associated with adverse changes in blood glucose values.
"The publication of nebivolol's first U.S. clinical trial further reinforces its longstanding use in patients worldwide," said Neil Shusterman, M.D., Senior Vice President, Clinical Development, Forest Research Institute. "The majority of Americans afflicted with this disease are still not controlled, so clearly there is a need for more treatment options. This study showed that nebivolol significantly lowered blood pressure in patients with mild-to-moderate hypertension and we anticipate it will be an important therapy for physicians."
Hypertension, also known as high blood pressure, affects approximately 72 million people in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range. If left untreated, hypertension can eventually damage important organs such as the heart, brain, eyes or kidneys. High blood pressure greatly increases the risk of certain health problems such as stroke, heart attack, and kidney failure.
Nebivolol is a selective beta 1-blocker with vasodilating properties and is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral(R) * (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2007, and on Form 10-Q for the period ended June 30, 2007.
|SOURCE Forest Laboratories, Inc.|
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