We currently market two respiratory-related products:
- NIOX® for use in asthma management.
- Tudorza® for the treatment of chronic obstructive pulmonary disease under our US commercial collaboration with AstraZeneca.
We plan to launch the recently approved chronic obstructive pulmonary disease treatment Duaklir® in the United States in the second half of 2019.
Circassia’s novel 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 and Germany 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
- reducing exacerbations.
NIOX® US Use and Risks Statement
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. NIOX VERO is suitable for children, approximately 7 – 17 years, and adults 18 years and older.
FeNO measurements provide 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. The 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 cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anaesthesiology.
Circassia markets Tudorza® Pressair® in the United States as part of the company’s commercial collaboration with AstraZeneca. Tudorza® is indicated for the long-term, maintenance treatment of bronchospasm associated with COPD. Tudorza® is presented as a dry powder formulation of the long-acting antimuscarinic agent (LAMA) aclidinium bromide, for administration twice daily by oral inhalation using the breath-actuated multi-dose dry powder inhaler, Pressair®.