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Melius Pharma Current treatment of chronic cough in IPF and unmet need.jpeg

Current treatment of chronic cough in IPF and unmet need

No safe and efficacious treatment for IPF cough exists

Although chronic cough is one of the major symptoms of IPF and significantly impairs patients’ quality of life, there is no approved treatment for the indication of cough in IPF.

It is important to identify and treat potential modifiable causes of cough such as gastro-esophageal reflux disease (GERD), which is common in IPF. In most patients, however, chronic cough persists.

Current best practice

Current best practice efforts to control cough in IPF include standard pharmacological interventions for cough and breathing symptoms and supportive therapy. • Attempts at symptomatic relief usually start with conventional anti-cough therapies (antitussives) such as dextromethorphan and codeine, which, however, do not provide satisfactory symptom relief in most patients. • Opiates, a class of painkillers, may be used to reduce anxiety, cough reflex and shortness of breath but are associated with side effects such as unwanted sedation, constipation, nausea, and vomiting, and may not be very effective for cough reduction in many patients. • Corticosteroids are sometimes used to try and treat cough, but here too, significant side effects and lack of proven effectiveness pose challenges. • Supportive therapy such as physical exercise, pulmonary physiotherapy, smoking cessation and education can improve patients’ quality of life and slow disease progression to some extent but are usually insufficient to reduce cough to a significant degree.

Unmet need

Unfortunately, most IPF patients’ chronic dry cough is refractory to standard pharmacotherapy and there is a large unmet need for a well-tolerated treatment that reduces cough frequency and severity in IPF. Life expectancy for most patients diagnosed with IPF is limited to a few years and maintaining the best possible quality of life is paramount. Cough has been reported by patients as one of the most burdensome symptoms – and the negative physiological and psychosocial consequences exert a significant strain on affected persons. By and large inadequate symptomatic relief at the cost of potentially serious side effect in the case of opiates and steroids means that an effective new treatment should be safe and well-tolerated. ME-015 is an oral investigational product that has been on the market in Japan for other indications for >20 years and has an excellent safety and tolerability profile in both, clinical studies and real-world use. ME-015’s could easily be added to IPF patient’s daily medications to be taken at home. Melius Pharma currently assesses ME-015 as a potential treatment for cough in IPF in a Phase 2 clinical trial.


1. Richeldi et a. Lancet 2017;389:1941-52. 2. Bajwah et al. Lung 2012;190:215-20. 3. Bajwah et al. Thorax 2013;68:867-79. 4. Hope-Gill et al. Am J Respir Crit Care Med 2003;168;995-1002. 5. Ryerson et al. Respir Med 2014;108:203-10. 6. Dowman et al Cochrane Databaste Syst Rev 2014;10:CD006322.

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