- Pharmaxis
- Home
- About Us
- Company Overview
- Products
Products
In addition to its first commercial product, Aridol, Pharmaxis has a strong suite of products in development, focused on treating respiratory diseases. The target disease states are under-treated and many have broad patient bases.
Aridol
Pharmaxis' first commercial product, Aridol is an innovative lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness.
By having patients inhale Aridol via a simple hand-held device, doctors can determine the severity of a patient's inflammation and prescribe the right amount of medication to bring it under control. The Aridol challenge test potentially prevents inappropriate treatment and may help patients better comply with their therapies.
Aridol is approved for sale in Australia, major European countries, Korea and Pharmaxis has filed a New Drug Application (NDA) for the approval of Aridol in the United States. It is the first and only approved Europe-wide lung function test and the world's first approved indirect challenge test for asthma, a condition which affects 52 millions people worldwide.
Aridol is involved in investigator-sponsored clinical trials worldwide, treating thousand of patients. It has also been included in both international and Australian official guidelines for managing asthma — recognition and endorsement by both global and Australian experts that Aridol is a significant addition to the tools available to help asthma patients. Bodies and guidelines endorsing Aridol include:
- International Olympic Committee Medical Commission's Independent Panel
- US Asthma Management Guidelines
- Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention
- World Anti-Doping Agency
- Australian Asthma Management Handbook
Recent Aridol Milestones- Aridol launched in 12 European countries and Korea using distribution partners
- New Drug Application accepted for review by the United States FDA
- Presentations at American Thoracic Society international conference
Upcoming Aridol Events- Response from FDA on Aridol New Drug Application
- Aridol to launch in Korea and Germany
Aridol home page
Bronchitol
Pharmaxis' key product in development, Bronchitol, is a drug designed to reduce the amount of mucus build-up in the lungs of patients suffering from chronic respiratory conditions.
Pharmaxis is developing Bronchitol for diseases including cystic fibrosis, bronchiectasis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand-held inhaler. Bronchitol hydrates the lungs, helps restore normal lung clearance, and allows patients to clear mucus more effectively. Clinical studies have shown Bronchitol to be safe, effective, and well tolerated in treating patients with both cystic fibrosis and bronchiectasis.
The results from a major Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated that Bronchitol is a safe and effective treatment. There have been limited therapeutic advances in the past decade to help clear congested lungs for patients with cystic fibrosis, a condition which affects 75,000 people worldwide.Bronchitol has been awarded fast-track status in the U.S., and orphan drug designation in both the US and EU.
The product is also being developed for use in bronchiectasis, a disease affecting 580,000 globally. Bronchitol will be the first targeted medication for this condition in over 20 years. A Phase 3 clinical trial of Bronchitol in people with bronchiectasis found that it delivered a highly significant improvement in users' quality of life. A second Phase 3 clinical trial is in progress around the world and is studying the effects of Bronchitol on reducing the infectious episodes, antibiotic use and hospitalization stays for patients with bronchiectasis.
Recent Bronchitol Milestones- A pivotal Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated that Bronchitol is safe and effective for improving lung function.
- An oral presentation of the cystic fibrosis phase 3 trial results at the European annual cystic fibrosis scientific meeting
Upcoming Bronchitol Events- Completion of enrolment for the second Phase 3 cystic fibrosis trial
- Submission of marketing authorisation application for Bronchitol in Europe
- European marketing approval for Bronchitol to treat cystic fibrosis
- Results of the second Phase 3 clinical trial in adults and children with cystic fibrosis
Bronchitol home page