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news.Pharmaxis, a specialty pharmaceutical company, has submitted a marketing application for Bronchitol, a mucus clearing agent, to the Therapeutic Goods Administration division of the Australian government.
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If approved, Pharmaxis will be authorized to market Bronchitol in Australia for the treatment of bronchiectasis. The application is based on a multicentre Phase III clinical trial involving more than 360 subjects which evaluated the safety and efficacy of Bronchitol for inhalation in subjects with bronchiectasis.
All of the primary efficacy end points were positive and statistically significant, and Bronchitol was shown to be well tolerated with no serious adverse events attributed to treatment. After being accepted for evaluation, the Therapeutic Goods Administration has 255 working days to review the application lodged by Pharmaxis.
Bronchitol is also under development as a twice daily inhalation therapy for people with cystic fibrosis with two large Phase III trials currently underway.
Alan Robertson, CEO of Pharmaxis, said: “Pharmaxis is dedicated to the development of safe and effective treatments for airway diseases, and we continue to work closely with regulatory authorities worldwide to bring Bronchitol to patients as quickly as possible.”