We currently market NIOX® around the world for use in asthma management and Tudorza® and Duaklir® in the United States for the maintenance treatment of chronic obstructive pulmonary disease.
Circassia’s NIOX® products are used to assist asthma management around the world. The current generation, NIOX VERO®, is approved in a number of countries, and is available in many major markets including the US, EU, Japan and China. We market the products directly in the United States, United Kingdom, China, Germany and Italy and also provide NIOX® through an international network of distributors.
Monitoring airway inflammation – monitoring asthma
Allergic airway inflammation is the major underlying cause of asthma. NIOX® exploits the discovery that patients with allergic airway inflammation generally have higher than normal levels of nitric oxide in their exhaled breath. By measuring the concentration of this nitric oxide (the fractional exhaled nitric oxide or FeNO), clinicians can evaluate allergic airway inflammation in patients with underlying asthma.
As a result, NIOX® is used to improve asthma management by assisting in:
- determining responsiveness to inhaled corticosteroids
- tailoring inhaled steroid use
- monitoring treatment compliance
- reduces the likelihood of exacerbations in patients at risk for future events compared to traditional monitoring.
Important Safety Information Regarding NIOX VERO® (United States)
NIOX VERO® is a portable system for the non-invasive, quantitative, simple and safe measurement of Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. Measuring the fractional NO concentration in expired breath (FeNO) provides the physician with means of evaluating an asthma patient’s response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO is suitable for children, 7–17 years, and adults 18 years and older. NIOX VERO can be operated in two exhalation modes, 10 seconds or 6 seconds. The 10-second test mode is for age 7 and up. The 6-second test mode is for ages 7–10 only when a 10-second test is not successful. NIOX VERO cannot be used with infants or by children under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
NIOX VERO® and NIOX® are registered trademarks of Circassia AB.
Circassia markets Tudorza® Pressair® in the United States, where it is indicated for the maintenance treatment of patients with COPD. Tudorza® is presented as a dry powder formulation of the long-acting muscarinic antagonist (LAMA) aclidinium bromide, for administration twice daily by oral inhalation using the breath-actuated multi-dose dry powder inhaler, Pressair®.
INDICATIONS AND USAGE
Tudorza® Pressair® (aclidinium bromide inhalation powder) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
IMPORTANT SAFETY INFORMATION
- TUDORZA PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or whohave hypersensitivity to aclidinium bromide or any of the excipients
- TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie,rescue therapy)
- Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue,or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of TUDORZA PRESSAIR. Additionally, inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If any of these occurs, treatment with TUDORZA PRESSAIR should bestopped and other treatments considered
- TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma orprostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physicianimmediately should any worsening of glaucoma or worsening of urinary retention develop
- 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 TUDORZAPRESSAIR vs placebo, respectively. In a long-term cardiovascular safety trial of up to 3 years, theadverse reactions (occurring at a rate of ≥2 % and more common than placebo) were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiacfailure congestive, cellulitis, and gastroesophageal reflux disease
1. TUDORZA PRESSAIR (aclidinium bromide inhalation powder) [prescribing information]. Wilmington,DE: AstraZeneca Pharmaceuticals LP; 2019
TUDORZA PRESSAIR is marketed by Circassia Pharmaceuticals Inc. Circassia is a registered trademark of Circassia Limited. TUDORZA is a registered trademark of ALMIRALL, S.A. PRESSAIR is a registered trademark of the AstraZeneca group of companies.
Duaklir® Pressair® is a combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate administered twice daily via the breath-actuated multi-dose dry powder inhaler, Pressair®. Circassia markets Duaklir® Pressair® in the United States, where it is indicated for the maintenance treatment of patients with COPD.
INDICATIONS AND USAGE
DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
IMPORTANT SAFETY INFORMATION
- DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate inhalation powder) is only indicated for use in COPD and is not indicated for use in asthma. Use of a long-acting beta2-adrenergic agonist (LABA) as monotherapy, including formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma and increases the risk of asthma-related death. When LABA are used in fixed-dose combinations with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone.
- DUAKLIR PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or formoterol fumarate or any component of the product
- DUAKLIR PRESSAIR is not indicated for the treatment of acute episodes of bronchospasm (i.e. rescue therapy)
- Do not initiate DUAKLIR PRESSAIR with an additional medicine containing a LABA because of risk of overdose or in acutely deteriorating COPD
- Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of DUAKLIR PRESSAIR. Additionally, inhaled medicines, including DUAKLIR PRESSAIR, may cause paradoxical bronchospasm which may be life threatening. If any of these occurs, immediate treatment with a short acting bronchodilator should be initiated and treatment with DUAKLIR PRESSAIR should be stopped and alternative therapy initiated
- DUAKLIR PRESSAIR should be used with caution in patients with cardiovascular and convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, hypokalemia, hyperglycemia, narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
- The most common adverse reactions (≥3% incidence and more common than placebo) were upper respiratory tract infection (8.9% vs 6.3%), headache (6.3% vs 5.1%), and back pain (3.8% vs 3.4%) for DUAKLIR PRESSAIR vs placebo, respectively. Other adverse reactions reported in clinical studies (>1% but less than 3% and more common than placebo) with DUAKLIR PRESSAIR were cough, sinusitis, influenza, tooth abscess, insomnia, dizziness, dry mouth, oropharyngeal pain, muscle spasm, musculoskeletal pain, arthralgia, pain in extremity, urinary tract infection, and increased blood creatine phosphokinase
DUAKLIR PRESSAIR is marketed by Circassia Pharmaceuticals Inc. Circassia is a registered trademark of Circassia Limited. DUAKLIR is a registered trademark of ALMIRALL, S.A. PRESSAIR is a registered trademark of the AstraZeneca group of companies.