Forest Laboratories, Inc (NYSE: 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' (NYSE: 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.
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