FDA Advisory Committee Recommends Approval of Tiotropium Respimat for the Maintenance Treatment of COPD Boehringer Ingelheim Pharmaceuticals, Inc.
Published: August 24th, 2014
By a News Reporter-Staff News Editor at Clinical Trials Week -- Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva(®) Respimat(®) (see also Boehringer Ingelheim Pharmaceuticals, Inc.).
The Advisory Committee voted that existing data supports approval after a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium in the RESPIMAT inhaler. One of these trials, TIOSPIR, the largest clinical trial conducted to date in patients with COPD, collected data from more than 17,000 COPD patients from 50 countries.
"As a practicing physician, it's essential to have multiple treatment choices available when assessing how to help people affected by this devastating disease," said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center.
The Advisory Committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval.
"We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium RESPIMAT in the U.S.," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium RESPIMAT would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option."
RESPIMAT is a multi-dose, propellant-free inhaler that uses mechanical energy to generate a slow-moving mist to deliver tiotropium, the same active ingredient as Spiriva(®) HandiHaler(®) (tiotropium bromide inhalation powder). If approved, tiotropium RESPIMAT would provide physicians and their patients with a choice between a mist and dry powder inhaler for tiotropium.
The availability and continued use of SPIRIVA HandiHaler is not affected by the Advisory Committee vote or subsequent FDA decision. SPIRIVA HandiHaler has an established efficacy and safety profile based on 29 placebo controlled clinical trials in over 12,000 patients.
About Spiriva(®) HandiHaler(®) (tiotropium bromide inhalation powder) SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing airways. COPD includes chronic bronchitis, emphysema or both.
SPIRIVA HandiHaler also reduces the likelihood of flare-ups (COPD exacerbations), which are new or worsening of symptoms in patients with COPD.
Important Safety Information for Spiriva HandiHaler (tiotropium bromide inhalation powder) SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of SPIRIVA capsules.
SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.
Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA HandiHaler. Additionally, inhaled medicines, including SPIRIVA HandiHaler, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA HandiHaler should be stopped and other treatments considered.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA HandiHaler.
Use with caution in patients with severe hypersensitivity to milk proteins.
SPIRIVA HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.
Since dizziness and blurred vision may occur with the use of SPIRIVA HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.
As SPIRIVA HandiHaler is a predominantly renally excreted drug, SPIRIVA HandiHaler use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of <= 50 mL/min).
SPIRIVA HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.
SPIRIVA HandiHaler may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.
The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia, and arthralgia.
SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.
SPIRIVA capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.
Please refer to the Instructions for Use for additional information on the use of SPIRIVA HandiHaler.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.
Click here for full Spiriva Prescribing Information, Patient Information and Instructions for Use.
Keywords for this news article include: Boehringer Ingelheim Pharmaceuticals Inc., FDA Actions, Hypersensitivity, Clinical Trials and Studies, Government Agencies Offices and Entities.
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