Specialist pharmaceutical company Pharmaxis Ltd has received national approval to market Aridol in Germany. Aridol is indicated for measuring airway hyperresponsiveness and has been approved in 14 European countries under the mutual recognition procedure (MRP). The necessary national approvals that follow the MRP have now been received for Denmark, Germany, Ireland, The Netherlands, Portugal, Sweden, and the United Kingdom.
In Germany a total of 660,000 lung function tests are conducted annually, of which approximately 90 per cent are conducted by office-based physicians and the remainder in the major hospitals. To enter the market, Pharmaxis will first negotiate with insurance companies that cover the office-based physician market before launching with a local distributor.
A simple-to-use airways inflammation test, Aridol is a dry powder administered to patients' lungs via a small hand-held inhaler. Doctors can use the results of this test toc identify airway hyperresponsiveness - a hallmark of asthma. Medications can be adjusted according to the severity of the disease.
"We are pleased that Aridol is becoming globally recognised as a useful test for identifying airway hyperresponsiveness," said Pharmaxis CEO Dr Alan Robertson. "With this latest approval, Aridol is on the way to becoming the worldwide standard for detecting sensitive airways in people with conditions such as asthma.
"The Aridol test provides objective information on airway hyperresponsiveness and assists in the diagnosis and assessment of severity of asthma and how much medication should be used".
As well as being included as one of the tests recommended by the International Olympic Committee - Medical Commission Independent Panel and the World anti-doping agency, Aridol is also included in the GINA Report of Global Strategy for asthma management and prevention, the US Asthma Management Guidelines, the British Guideline on the Management of Asthma and the Australian Asthma Management Handbook.
Aridol is the first and only approved Europe-wide lung function test and the world's first approved indirect challenge test for asthma. The Aridol lung function test, developed by Australian researchers and Pharmaxis, helps doctors more accurately determine the severity of a patient's airways inflammation - a hallmark of asthma - and allow prescription of the right amount of medication.
The simple 15-25 minute test uses powdered mannitol, which the patient inhales in increasing doses. In asthmatic patients, this causes the airways to narrow and contract, which is detected by measuring the amount of air a person can exhale in one second. The smaller the dose required to cause contraction, the more severe the patient's asthma. People without airway inflammation do not respond to an Aridol challenge test. Asthma affects 52 million people worldwide, many of whom may be receiving inappropriate medication because of the absence of an objective test - until now. Clinical trial results suggest that 25 -per cent of asthmatic patients are being treated with sub-optimal dosages of asthma medication, and up to 17 per cent could reduce their medication without adverse effects.
Pharmaxis is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and autoimmune diseases. Its development pipeline of products includes Aridol for the management of asthma, Bronchitol for bronchiectasis, cystic fibrosis, and chronic bronchitis and PXS64 for the treatment of multiple sclerosis.