Forest Laboratories, Inc. (NYSE: FRX) announced today that
Daliresp™ (roflumilast) will be available in pharmacies throughout
the United States by mid-June. The U.S. Food and Drug
Administration (FDA) recently approved Daliresp as a treatment to
reduce the risk of chronic obstructive pulmonary disease (COPD)
exacerbations in patients with severe COPD associated with chronic
bronchitis and a history of exacerbations.
Daliresp is the first and only selective phosphodiesterase-4
(PDE4) inhibitor approved and is an oral tablet taken once
daily.
Visit www.daliresp.com for more information about Daliresp.
About COPD
COPD is an under-diagnosed, progressive, irreversible lung
disease and is the third leading cause of death in the U.S.
Approximately 12 million people in the U.S. are currently diagnosed
with COPD and an additional 12 million are likely to have the
disease and not know. Approximately half of COPD patients treated
by a physician with controller medications have severe COPD. Of the
patients diagnosed with severe COPD, almost three quarters, or 2.8
million, have chronic bronchitis.
Symptoms of COPD include breathlessness, chronic cough and
excessive production of phlegm. A significant worsening of symptoms
- called an exacerbation - can last several weeks and often
requires substantial medical intervention, including
hospitalization. Exacerbations can result in worsening health
status, lung function decline, and increased risk of death.
About Daliresp (roflumilast)
Daliresp (500 mcg) 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 lung cells. Daliresp is not a steroid, is not a
bronchodilator, and is not indicated for the relief of acute
bronchospasm.
In August 2009 Forest Laboratories and Nycomed entered into a
definitive collaboration and distribution agreement pursuant to
which Forest acquired an exclusive license for Daliresp in the
United States. Roflumilast is marketed in the EU, Canada, and other
territories as Daxas®.
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
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%).
Use in Specific Populations
There are no adequate and well controlled studies in pregnant
women. Daliresp should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Daliresp should not be used during labor and delivery.
Daliresp should not be used by women who are nursing as
excretion of roflumilast and/or its metabolites into human milk is
probable and there are no human studies that have investigated
effects of Daliresp on breast-fed infants.
The safety and effectiveness of Daliresp have not been
established in patients less than 18 years of age.
No overall differences were observed in safety or effectiveness
between patients greater than or less than 65 years of age.
About Nycomed
Nycomed is a privately owned global pharmaceutical company with
a diversified portfolio focused on branded medicines in
gastroenterology, respiratory and inflammatory diseases, pain,
osteoporosis and tissue management. A range of OTC products
completes the portfolio. Its R&D is structured around
collaborations. In-licensing and expanding in emerging markets are
cornerstones of the company's growth strategy. Nycomed employs
12,500 associates worldwide, and its products are sold in more than
100 countries. It has strong platforms in Europe and in
fast-growing markets such as Russia/CIS, Latin America, Asia and
the Middle East. In the US and Japan its products are available
through best in class partners. Headquartered in Zurich,
Switzerland, the company generated total sales of € 3.2 billion in
2010 and an adjusted EBITDA of € 851 million. For more information
visit www.nycomed.com
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 and respiratory
medicine. The Company'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.
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