DUBLIN, May 16, 2016 /PRNewswire/ -- Allergan
plc (NYSE: AGN), a leading global pharmaceutical company, today
announced that data on nebivolol and an investigational fixed-dose
combination (FDC) of nebivolol and valsartan will be presented at
the American Society of Hypertension (ASH) Annual Scientific
Meeting scheduled May 13-17, 2016 in
New York. The U.S. Food & Drug
Administration (FDA) is currently reviewing a New Drug Application
for the nebivolol/valsartan FDC for the treatment of
hypertension. Nebivolol is approved and marketed in the US as
BYSTOLIC for the treatment of hypertension, to lower blood
pressure.
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The posters include data from multiple hypertension studies.
"Nearly half of all hypertension patients in the U.S. have not
achieved blood pressure control," said David Nicholson, Chief R&D Officer at
Allergan. "Allergan is dedicated to continuing to develop and
provide treatment options to help physicians and patients across
various populations achieve control."
The following four posters will be presented on:
Monday, May 16, 2016, Noon –
1:00 PM ET
- Increased Placebo Response in Hispanics Compared to Other
Ethnic Groups in Hypertension Trials: An Analysis of Nebivolol
Trials authored by Thomas D.
Giles, Henry Punzi, Madhuja
Mallick, William Ferguson,
Mehul Patel
- The Effects of Nebivolol-Valsartan Single-Pill Combinations
in Reducing Blood Pressure in Patients With Stage I or II
Hypertension authored by M. A.
Weber, G. L. Bakris,
W. B. White, M. Patel, D. Bharucha,
L. Xie
- The Effects of Nebivolol on Weight in Individuals with
Hypertension authored by John
Flack, Madhuja Mallick, Mehul Patel
- Additivity of Nebivolol/Valsartan Single-Pill Combination
Versus Other Single-Pill Combinations for Hypertension authored
by J. Ishak, M. Rael, H. Punzi, A. Gradman, M. Patel, S. Ali, W.
Ferguson, J. Neutel
About Hypertension
According to the U.S. Centers for Disease Control and
Prevention, hypertension has been called the "silent killer"
because it often has no warning signs or symptoms and has been
associated with serious cardiovascular (CV) risks, such as stroke
and myocardial infarction. Hypertension represents a significant
public health issue with high prevalence in the United States. According to the National
Institute for Health Statistics, approximately 30 percent of adults
in the U.S. have hypertension. Inadequate control of hypertension
is a significant public health problem, with approximately half of
all patients still not achieving target goals. 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 blood pressure reduction that is largely
responsible for those benefits. There are no controlled
trials demonstrating risk reduction with nebivolol and the
investigational nebivolol/valsartan FDC. In addition,
approximately two-thirds of hypertensive patients will require more
than one drug to achieve blood pressure goals, further emphasizing
the importance of antihypertensive drug combinations and of studies
of safety and efficacy such as this program's.
About Nebivolol and Nebivolol/Valsartan
Nebivolol (marketed in the U.S. as BYSTOLIC®) is a
cardioselective beta blocker up to and including the 10mg dose and
in extensive metabolizers. While nebivolol's mechanism of action
has not been definitively established, possible factors that may be
involved include vasodilation, decreased peripheral vascular
resistance, 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.
Nebivolol/Valsartan FDC is an investigational combination of
nebivolol and 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.
Like nebivolol, valsartan has been well studied in many different
patient populations and is an effective antihypertensive agent.
This combination is currently under review by the FDA for the
treatment of hypertension.
IMPORTANT SAFETY INFORMATION FOR BYSTOLIC
Contraindications
- BYSTOLIC is contraindicated in patients with severe
bradycardia, heart block greater than first degree, cardiogenic
shock, decompensated cardiac failure, sick sinus syndrome (unless a
permanent pacemaker is in place), severe hepatic impairment
(Child-Pugh >B), and in patients who are hypersensitive to any
component of this product.
Warnings and Precautions
- Do not abruptly discontinue BYSTOLIC therapy in patients with
coronary artery disease. Severe exacerbation of angina, myocardial
infarction, and ventricular arrhythmias have been reported
following the abrupt discontinuation of therapy with beta blockers.
Myocardial infarction and ventricular arrhythmias may occur with or
without preceding exacerbation of the angina pectoris. Caution
patients without overt coronary artery disease against interruption
or abrupt discontinuation of therapy. As with other beta blockers,
when discontinuation of BYSTOLIC is planned, carefully observe and
advise patients to minimize physical activity. Taper BYSTOLIC over
1 to 2 weeks when possible. If the angina worsens or acute coronary
insufficiency develops, restart BYSTOLIC promptly, at least
temporarily.
- BYSTOLIC was not studied in patients with angina pectoris or
who had a recent MI.
- In general, patients with bronchospastic diseases should not
receive beta blockers.
- Because beta blocker withdrawal has been associated with an
increased risk of MI and chest pain, patients already on beta
blockers should generally continue treatment throughout the
perioperative period. If BYSTOLIC is to be continued
perioperatively, monitor patients closely when anesthetic agents
which depress myocardial function, such as ether, cyclopropane, and
trichloroethylene are used. If beta-blocking therapy is withdrawn
prior to major surgery, the impaired ability of the heart to
respond to reflex adrenergic stimuli may augment the risks of
general anesthesia and surgical procedures.
The beta-blocking effects of BYSTOLIC can be reversed by beta
agonists, eg, dobutamine or isoproterenol. However, such patients
may be subject to protracted severe hypotension. Additionally,
difficulty in restarting and maintaining the heartbeat has been
reported with beta blockers.
- Beta blockers may mask some of the manifestations of
hypoglycemia, particularly tachycardia. Advise patients subject to
spontaneous hypoglycemia and diabetic patients receiving insulin or
oral hypoglycemic agents about these possibilities.
- Beta blockers may mask clinical signs of hyperthyroidism, such
as tachycardia. Abrupt withdrawal of beta blockers in these
patients may be followed by an exacerbation of symptoms or may
precipitate a thyroid storm.
- Beta blockers can precipitate or aggravate symptoms of arterial
insufficiency in patients with peripheral vascular disease.
- Because of significant negative inotropic and chronotropic
effects in patients treated with beta blockers and calcium channel
blockers of the verapamil and diltiazem type, monitor the ECG and
blood pressure of patients treated concomitantly with these
agents.
- When BYSTOLIC is co-administered with an inhibitor or an
inducer of CYP2D6, monitor patients closely and adjust the
nebivolol dose according to blood pressure response. The dose of
BYSTOLIC may need to be reduced. When BYSTOLIC is administered with
fluoxetine, significant increases in d-nebivolol may be observed
(ie, an 8-fold increase in AUC and a 3-fold increase in
Cmax for d-nebivolol).
- Renal clearance of nebivolol is decreased in patients with
severe renal impairment. In patients with severe renal impairment
(ClCr less than 30 mL/min) the recommended initial dose is
2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has
not been studied in patients receiving dialysis.
- Metabolism of nebivolol is decreased in patients with moderate
hepatic impairment. In patients with moderate hepatic impairment,
the recommended initial dose is 2.5 mg once daily; titrate up
slowly if needed. BYSTOLIC has not been studied in patients with
severe hepatic impairment and therefore it is not recommended in
that population.
- Patients with a history of severe anaphylactic reactions to a
variety of allergens may be more reactive to repeated challenge and
may be unresponsive to the usual doses of epinephrine while taking
beta blockers.
- In patients with known or suspected pheochromocytoma, initiate
an alpha blocker prior to the use of any beta blocker.
Adverse Reactions
- The most common adverse events with BYSTOLIC versus placebo
(approximately ≥1% and greater than placebo) were headache,
fatigue, dizziness, diarrhea, nausea, insomnia, chest pain,
bradycardia, dyspnea, rash, and peripheral edema. The most common
adverse events that led to discontinuation of BYSTOLIC were
headache (0.4%), nausea (0.2%), and bradycardia (0.2%).
Drug Interactions
- Use caution when BYSTOLIC is co-administered with CYP2D6
inhibitors (quinidine, propafenone, fluoxetine, paroxetine,
etc).
- Do not use BYSTOLIC with other beta blockers.
- Both digitalis glycosides and beta blockers slow
atrioventricular conduction and decrease heart rate. Concomitant
use can increase the risk of bradycardia.
- BYSTOLIC can exacerbate the effects of myocardial depressants
or inhibitors of AV conduction, such as certain calcium antagonists
(particularly of the phenylalkylamine [verapamil] and
benzothiazepine [diltiazem] classes), or antiarrhythmic agents,
such as disopyramide.
Use in Specific Populations
- Use BYSTOLIC during pregnancy only if the potential benefit
justifies the potential risk to the fetus. BYSTOLIC is not
recommended during nursing.
- The safety and effectiveness of BYSTOLIC have not been
established in pediatric patients.
- In a placebo-controlled trial of 2128 patients (1067 BYSTOLIC,
1061 placebo) over 70 years of age with chronic heart failure
receiving a maximum dose of 10 mg per day for a median of 20
months, no worsening of heart failure was reported with nebivolol
compared to placebo. However, if heart failure worsens, consider
discontinuation of BYSTOLIC.
Please also see full Prescribing Information for BYSTOLIC
available at www.bystolichcp.com
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
Allergan Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the risks associated with acquisition
transactions; the difficulty of predicting the timing or outcome of
FDA approvals or actions, if any; the impact of competitive
products and pricing; market acceptance of and continued demand for
Allergan's products; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Quarterly Report on Form
10-Q for the quarter ended March 31, 2016 (such periodic
public filings having been filed under the "Actavis plc" name) and
from time to time in Allergan's other investor communications .
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa DeFrancesco
+1 (862) 261 7152
investor.relations@allergan.com
Media:
Mark Marmur
+1 (862) 261 7558
mark.marmur@allergan.com
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SOURCE Allergan plc