Forest Laboratories Submits a New Drug Application for Nebivolol and Valsartan Combination in Hypertension
February 27 2014 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) announced that it has
submitted a New Drug Application (NDA) to the Food and Drug
Administration (FDA) for a fixed dose combination (FDC) of
nebivolol and valsartan for the treatment of hypertension.
The application for the treatment of hypertension includes
results from an 8-week randomized, double-blind, placebo-controlled
pivotal clinical trial in 4,161 hypertensive patients which studied
different fixed combinations of nebivolol 5, 10, and 20 mg with
valsartan 80, 160, and 320 mg versus placebo and compared to the
individual drugs alone. It also includes the results from a
52-week, open-label study which assessed long-term
safety/tolerability of the free tablet combination of nebivolol and
valsartan in 807 patients.
“Despite the available options for the treatment of
hypertension, many patients remain uncontrolled. Combining the
well-established hypertension drugs, nebivolol and valsartan, could
provide physicians and patients with an additional convenient
option,” said Marco Taglietti, MD, Chief Medical Officer and EVP,
Drug Development and Research at Forest Laboratories, Inc.
The single pivotal nebivolol/valsartan FDC trial was designed to
meet the required regulatory “Combination Rule,” comparing the
fixed dose combination against the highest approved doses of each
component drug.
About Hypertension
Hypertension has been described as a “neglected disease” because
of the lack of attention given to it and the serious cardiovascular
(CV) consequences of having high Blood Pressure (BP), such as
strokes and Myocardial Infarction (MI). The prevalence of
hypertension is on the rise. According to the National Institute of
Health Statistics, 28.6% of adults in the United States (~88
million) have hypertension. Inadequate treatment of hypertension is
a significant public health problem. Numerous antihypertensive
drugs, from a variety of pharmacologic classes and with different
mechanisms of action, have been shown in randomized controlled
trials to reduce CV morbidity and mortality, and it can be
concluded that it is BP reduction that is largely responsible for
those benefits. Elevated systolic or diastolic pressure causes
increased CV risk, and the absolute risk increase per mm Hg is
greater at higher blood pressures, so even modest reductions of
severe hypertension can provide substantial benefit. Two-thirds of
patients will require more than one drug to achieve BP goals.
About Nebivolol/Valsartan FDC
Nebivolol/valsartan (5/80mg, 5/160mg, 10/160mg, 10/320mg, and
20/320mg) is an investigational fixed dose combination.
Nebivolol/valsartan FDC combines two FDA-approved, once-daily,
blood pressure lowering agents with different mechanisms of action.
It is being evaluated as a potential treatment for hypertension in
patients who need combination therapy.
In the Phase III pivotal trial, the combination of nebivolol and
valsartan demonstrated statistically significant reductions in
diastolic blood pressure (DBP) vs. the highest approved doses of
both nebivolol alone (40mg) and valsartan alone (320mg) at 8 weeks,
which was the primary endpoint. The DBP reductions for the other
FDC doses versus corresponding monotherapies were also
statistically significant at 8 weeks. The FDC also met the key
secondary endpoint of change from baseline in systolic blood
pressure (SBP) at 8 weeks.
Treatment with nebivolol/valsartan FDC was well-tolerated in the
study. Across all FDC doses the most common adverse events
(incidence ≥ 2% and greater than placebo) were fatigue (0.9% to
2.3% vs. 1.1% in placebo) and dizziness (1.6% to 2.3% vs. 0.4% in
placebo).
Nebivolol (marketed in the U.S. as BYSTOLIC®) is cardioselective
up to and including the 10mg dose and in extensive metabolizers.
While nebivolol’s mechanism of action has not been definitively
established, possible factors include vasodilation and decreased
peripheral vascular resistance (PVR). Other possible factors
include reduced heart rate and myocardial contractility,
suppression of renin, and reduced sympathetic activity. Nebivolol
is indicated for the treatment of hypertension and is effective at
lowering blood pressure when taken alone or in combination with
other antihypertensive agents.
Valsartan is an angiotensin II receptor blocker (ARB) that
blocks the binding of angiotensin II to the AT1 receptor in many
tissues, such as vascular smooth muscle and the adrenal gland,
thereby preventing its vasoconstrictor and aldosterone-secreting
effects. Valsartan has been well studied in many different patient
populations and is an effective antihypertensive agent.
About Forest Laboratories
Forest Laboratories, Inc. (NYSE:FRX) is a leading, fully
integrated, specialty pharmaceutical company largely focused on the
United States market. The Company markets a portfolio of branded
drug products and develops new medicines to treat patients
suffering from diseases principally in the following therapeutic
areas: central nervous system, cardiovascular, gastrointestinal,
respiratory, anti-infective, and cystic fibrosis. Our strategy of
acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers
and acquisitions allows us to take advantage of attractive
late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. The Company is
headquartered in New York, NY. To learn more, visit Forest’s Web
Site at www.frx.com.
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 Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President - Investor Relationsmedia.relations@frx.comorAmanda
KaufmanMedia Relationsamanda.kaufman@frx.com
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