Forest to Present Aclidinium Bromide and Roflumilast Clinical Data at the American Thoracic Society
Forest to Present Aclidinium Bromide and Roflumilast Clinical Data at the American Thoracic Society (ATS) International Conference
NEW YORK--(BUSINESS WIRE)-- Forest Laboratories, Inc (NYS: FRX) today announced that they will present data related to aclidinium bromide and roflumilast at the American Thoracic Society (ATS) International Conference on May 17-22 in Philadelphia, PA. Seven posters, two poster discussion sessions and one late breaking abstract will be presented for aclidinium bromide. Roflumilast related data will be highlighted in four posters and three poster discussion sessions.
During the ATS session titled "Pharmacological Treatment of COPD: New Developments" on Monday, May 20th from 8:15 am-10:45 am, the following three poster discussion sessions will take place:
"Aclidinium Bromide Improves Static Lung Function and Hyperinflation in Patients with Moderate-to-Severe COPD"
"Aclidinium Bromide Improves Exercise Endurance and Dynamic Hyperinflation and Decreases Exertional Dyspnoea in Patients with Moderate-to-Severe COPD"
"Roflumilast Prevents Cigarette Smoke-Induced Airway Surface Liquid Volume Depletion in Primary Human Bronchial Epithelia Cultures"
Two additional posters discussions will be included in the session titled, "COPD: Implications of New GOLD Stratification and Phenotypes", scheduled for May 21st from 8:15 am-10:45 am.
"Comparison of Physician-Reported, Spirometry-Based And Risk Plus Symptoms Classification Systems Within a US Sample of Severe/Very Severe COPD Patients"
"Alignment of Current Treatment Patterns for Severe/Very Severe COPD Patients with Updated GOLD Recommendations: Results from a Nationally Representative Patient Survey and Chart Review"
Also being presented are the following poster presentations:
Aclidinium Bromide:
Low Incidence Of Anticholinergic Adverse Events With Twice-Daily Aclidinium Bromide: Data From ACCORD COPD I And ATTAIN (Poster F73: Sunday, May 19, 8:15 am-4:30pm)
Health-Related Quality Of Life And Work Productivity Of Employed COPD Patients With Nighttime And Early Morning Symptoms (Poster L73: Monday, May 20, 8:15am-4:30pm)
Twice-Daily Aclidinium In COPD Patients: Peak Measurements In A 12-Hour Serial Spirometry Subset Of Patients From ACCORD COPD I (Poster G34: Tuesday, May 21, 8:15am-4:30pm)
Efficacy Of Twice-Daily Aclidinium Bromide 400μg In Subgroups Of Patients With COPD (Poster G33: Tuesday, May 21, 8:15 am-4:30 pm)
Efficacy and Safety of Aclidinium Bromide Compared with Tiotropium and Placebo in Patients with Moderate-to-Severe COPD: a Phase IIIb Study (Poster G17: Tuesday, May 21, 8:15 am-4:30 pm)
Improvements in COPD Symptoms and Rescue Medication use with Aclidinium Bromide Compared with Tiotropium and Placebo: a Phase IIIb study (Poster G18: Tuesday, May 21, 8:15 am-4:30 pm)
Factors Associated With Nighttime And Early Morning Symptoms Among Patients With Chronic Obstructive Pulmonary Disease (Poster D69: Wednesday, May 22, 8:15 am-4:30 pm)
Roflumilast:
Evaluation of Major Adverse Cardiac Events in a One Year Placebo-Controlled Trial: Rationale and Design (Poster F68: Sunday, May 19, 8:15 am-4:30 pm)
Anti-Inflammatory Effects of Roflumilast N-Oxide in Glucocorticoid Insensitive Epithelial Cells Stimulated with Toll Like Receptor Agonists (Poster F86: Sunday, May 19, 8:15 am-4:30 pm)
Use of Electronic Health Records and Health Insurance Claims to Estimate the Burden of Exacerbations in COPD Patients within an Integrated Healthcare System (Poster H60: Monday, May 20, 8:15 am-4:30 pm)
Characteristics of COPD Patients Treated with Roflumilast During Hospitalization (Poster G70: Tuesday, May 21, 8:15 am-4:30 pm)
Finally, "Unreported Exacerbations of Chronic Obstructive Pulmonary Disease Are Associated with a Reduction in Health Status: Results from the ATTAIN Study" will be presented as an aclidinium-related late breaking abstract on Tuesday, May 21st at 10:00 am.
About TUDORZA PRESSAIR (aclidinium bromide)
TUDORZA PRESSAIR (aclidinium bromide inhalation powder) 400mcg is an anticholinergic for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. When given by inhalation, Tudorza produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle.
TUDORZA provides statistically significant improvements in bronchodilation, as measured by change from baseline in morning pre-dose trough FEV1 at 12 weeks (the primary endpoint) and 24 weeks compared to placebo. Mean peak improvements in lung function (FEV1) assessed after the first dose of TUDORZA were similar to those observed at week 12. TUDORZA is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy).
TUDORZA is administered using a multiple-dose dry powder inhaler, PRESSAIR, which delivers 60 doses of aclidinium bromide powder for inhalation. The PRESSAIR inhaler has a colored control window which confirms successful inhalation of the full dose and a dose indicator to let patients know how many doses remain in the inhaler. For a complete description of how to use the TUDORZA PRESSAIR inhaler and when to get a new inhaler, see the step-by-step Instructions for Use within the Prescribing Information.
Indication
TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Important Safety Information
TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy).
Inhaled medicines, including TUDORZA, may cause paradoxical bronchospasm. In addition, immediate hypersensitivity reactions may occur after administration of TUDORZA. If either of these occurs, treatment with TUDORZA should be stopped and other treatments considered.
TUDORZA should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to TUDORZA. Use with caution in patients with severe hypersensitivity to milk proteins.
The most common adverse reactions (≥3% incidence and greater than placebo) were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for TUDORZA vs placebo, respectively.
About DALIRESP (roflumilast)
DALIRESP (500mcg) is a selective PDE4 inhibitor that is indicated as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA
While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in the lung cells. DALIRESP is not a steroid, is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Indication
DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Important Safety Information
Contraindications
DALIRESP is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Warnings and Precautions
Treatment of Acute Bronchospasm
DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.
Psychiatric Events including Suicidality
Prescribers should advise patients, their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur, to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment if such events occur. Before using DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with DALIRESP.
Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. In controlled clinical trials 5.9% of patients treated with DALIRESP reported psychiatric adverse reactions vs 3.3% treated with placebo. The most common psychiatric adverse reactions were insomnia (2.4% vs 1.0%), anxiety (1.4% vs 0.9%), and depression (1.2% vs 0.9%). Three patients treated with DALIRESP experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) compared to one patient (suicidal ideation) treated with placebo.
Weight Decrease
Patients should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated and treatment discontinuation considered.
In addition to weight loss being reported as a common adverse reaction (7.5% of patients treated with DALIRESP vs 2.1% placebo), weight was prospectively assessed in two 1-year clinical trials. In these studies that compared DALIRESP to placebo, 20% vs 7% experienced moderate weight loss (5-10% of body weight) and 7% vs 2% experienced severe weight loss (>10% body weight). During the follow-up period after discontinuing DALIRESP, the majority of patients regained some of the weight they had lost.
Drug Interactions
Use with strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended, as they decrease the exposure and may reduce the therapeutic effectiveness of DALIRESP.
Adverse Reactions
In clinical trials the most common adverse reactions (≥2% and greater than placebo) were diarrhea (9.5% vs 2.7%), weight loss (7.5% vs 2.1%), nausea (4.7% vs 1.4%), headache (4.4% vs 2.1%), back pain (3.2% vs 2.2%), influenza (2.8% vs 2.7%), insomnia (2.4% vs 1.0%), dizziness (2.1% vs 1.1%), and decreased appetite (2.1% vs 0.4%).
About COPD
COPD, or chronic obstructive pulmonary disease, is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe. The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide. More than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke. WHO predicts that COPD will become the third leading cause of death worldwide by 2030. COPD is already the third leading cause of death in the U.S.
In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and chronic cough. As the condition worsens and breathlessness increases, daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult. New therapies to treat this debilitating disease may be of value.
About Forest Laboratories
Forest Laboratories' (NYS: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest's pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit 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, 212-224-6714
Vice President - Investor Relations
media.relations@frx.com
KEYWORDS: United States North America New York Pennsylvania
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