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.
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
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
- 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.
- 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%).
- 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.
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.
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