Patient Call Center Provides Product Education
and Reimbursement Support
Forest Laboratories, Inc. (NYSE:FRX) today announced the launch
of the STRIDE (Start Treatment, Real-time
Information, Disease Education) patient
support program to help those prescribed Tudorza® Pressair®
(aclidinium bromide inhalation powder) or Daliresp® (roflumilast)
by answering questions they may have about their chronic
obstructive pulmonary disease (COPD) treatment. COPD is a
progressive and debilitating lung disease characterized by
persistent airflow limitation that makes it hard to breathe.
The STRIDE program features a dedicated call center staffed by
registered nurses who have been trained to answer questions about
each product and reimbursement specialists prepared to address
inquiries related to insurance coverage and co-pay assistance. The
primary goal of the STRIDE program is to help Tudorza and Daliresp
patients receive the full benefits of their prescribed therapies.
This includes instruction on the proper use of the Pressair inhaler
with treatment education and useful tools to help increase
compliance with both prescribed therapies.
“The STRIDE patient support program is the first of its kind for
Forest and reinforces our commitment to the COPD community,” said
Gavin Corcoran, Executive VP Global Medicines Development. “The
important information and services provided through the STRIDE
program help patients learn more about their prescribed COPD
treatment and empower them to have more productive interactions
with their healthcare professionals.”
Patients and their caregivers can access the STRIDE program by
calling 1-855-STRIDE8 (787-4338) from Monday to Friday, 8:30
AM – 8:00 PM ET. More information about the STRIDE program and the
opportunity to join can also be found at
www.daliresp.com/startstride or
www.tudorza.com/startstride.
“STRIDE offers a unique opportunity to deliver 1:1 patient
support. As a registered nurse, I find it very rewarding to be here
for patients, providing real time answers to their questions about
Tudorza and Daliresp,” said Christina Richards, RN, manager of the
STRIDE Nurse COPD team.
The STRIDE patient support program is not a substitute for the
care of a qualified healthcare professional and the call center
cannot diagnose or treat callers.
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
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 and Its Products
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in five therapeutic areas: central
nervous system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Our strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows us to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. The Company is headquartered in New York, NY. To learn
more, visit www.FRX.com.
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, 212-224-6714Vice
President − Investor RelationsFrank.Murdolo@frx.comorAmanda
KaufmanMedia Relationsamanda.Kaufman@frx.com
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