Low dose morphine capsules have been licensed by the TGA for the treatment of chronic breathlessness.
The re-purposing of Kapanol sustained-release capsules (10mg and 20mg) from use in chronic pain to chronic breathlessness has been welcomed by palliative care specialist Professor David Currow, who was Chief Investigator in the Palliative Care Clinical Studies Collaborative (PaCCSC) that provided the data to show their safety and efficacy in this indication.
He said the listing would provide an effective additional treatment option for patients that can reduce their debilitating breathlessness symptoms.
“This world-first indication can safely improve the lives of the large number of people with disabling chronic breathlessness in our community and will change the future of research in chronic breathlessness,” said Professor Currow, who is Professor of Palliative Medicine at University of Technology, Sydney.
“Having a registered indication will provide impetus to expand the number of medications available for chronic breathlessness. It is likely to drive new areas of research in the laboratory and in the clinic directly with patients.”
The sustained-release morphine capsules are listed as a Schedule 8 (S8) medicine indicated for doses up to 30mg per 24 hours for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe COPD, cardiac failure, malignancy or other cause.
According to Professor Currow, patients should be commenced on 10mg per 24 hours and titrated carefully to a symptomatic response.
The product information states that in trials, when carefully titrated at doses up to 30 mg/day in people with severe COPD, morphine did not result in episodes of respiratory depression and tolerance was not reported.
It notes a recent meta-analyses of 12 trials of morphine for the reduction of chronic breathlessness showed a clinically meaningful reduction in breathlessness. Another review of 67 clinical studies of opioids for breathlessness found no evidence of clinically relevant respiratory adverse effects of opioids for chronic breathlessness including changes in blood gases or respiratory depression.
A recent commentary co-authored by Professor Currow and respiratory specialists in Thorax concluded that the “moderate level evidence to date supports that regular, low-dose morphine is the first-line pharmacological treatment for the relief of chronic breathlessness in severe illness.”
According to its listing on the Australian Register of Therapeutic Goods, the use of Kapanol for the reduction of chronic breathlessness should be restricted to situations where:
- the approved treatments for the underlying cause(s) of the breathlessness and non-pharmacological measures are not effective, and
- review by a respiratory, palliative care or other appropriate specialist has confirmed that treatment of the underlying cause(s) is optimal, and
- the breathlessness is having a significant impact on the patient’s quality of life, and the patient has been informed of the potential risks, and
- there is no psychiatric contraindication or history of drug abuse.
An application for PBS listing of Kapanol for chronic breathlessness will be considered by the Pharmaceutical Benefits Advisory Committee at its March meeting.