Forest Laboratories, Inc. Launches STRIDE Patient Support Program for COPD Franchise Products Tudorza® Pressair® and Daliresp®
Patient Call Center Provides Product Education and Reimbursement Support
NEW YORK--(BUSINESS WIRE)--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 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.”
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.
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.
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
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.
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.
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.
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%).
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.