Mayne Pharma treatment for chronic breathlessness approved by TGA

20 February 2019 |

Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the Therapeutic Goods Administration (TGA) has approved KAPANOL® low dose sustained-release 10mg and 20mg morphine capsules for the treatment of chronic breathlessness in patients with advanced disease.

Mayne Pharma’s CEO, Mr Scott Richards said “The repurposing of low dose morphine for chronic breathlessness is a world first registration for this indication. More than 70,000 Australians suffer from chronic breathlessness and will now have access to KAPANOL to manage their breathlessness symptoms. Many of the patients suffering from this condition are housebound and limited in their day-to-day activities. The clinical studies undertaken by Palliative Care Clinical Studies Collaborative (PaCCSC), under Professor David Currow, have shown the use of KAPANOL in severe breathlessness can reduce their debilitating breathlessness symptoms.”

Following an independent approach from Prof Currow, Mayne Pharma collaborated with government and academia on this program with funding also provided via grants obtained by PaCCSC from the National Health and Medical Research Council.

An application to the Pharmaceutical Benefits Advisory Committee has been made to expand the Pharmaceutical Benefits Scheme (PBS) reimbursement of KAPANOL to include this new treatment of chronic breathlessness.

This program is another example of the Company’s strategy to repurpose existing drugs into new therapeutic areas. The Company continues to progress the repurposing of SUBA®-itraconazole into certain cancers following completion of the Phase IIb clinical trial in Basal Cell Carcinoma Nevus Syndrome (BCCNS, commonly known as Gorlin Syndrome), with plans to commence a Phase III global pivotal trial this year in patients with BCCNS. In addition, the Company is working with the Kinghorn Cancer Centre and Hudson Institute of Medical Research to further understand and investigate the potential for SUBA-itraconazole as a novel treatment for various cancers.

(Source: Mayne Pharma)


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