Erdotin - new mucolytic for chronic bronchitis exacerbations

Galen has launched Erdotin (erdosteine) licensed as an expectorant and for the treatment of acute exacerbations of chronic bronchitis.

Pharmacology
Erdosteine is a homocysteine-derived expectorant. It undergoes metabolic conversion to give a thiol-containing compound that has mucolytic and free radical scavenging activity, thereby improving expectoration.

Clinical studies
In a randomised double-blind trial involving 200 subjects affected by chronic obstructive bronchitis, erdosteine 300mg twice daily co-administered with ciprofloxacin 500mg twice daily improved symptoms in 97% of patients versus 82% of patients receiving placebo and antibiotic1. The 24-hour excreatum volume was reduced in a higher percentage of subjects in the erdosteine and ciprofloxacin treatment group compared to placebo.

In a further study, involving 237 patients with acute infective exacerbations of chronic bronchitis, subjects were given erdosteine 300mg twice daily or placebo with amoxicillin 1500mg daily2.  Erdosteine was more active against the disease symptoms than placebo.

The majority of adverse events, both in the erdosteine and placebo group were related to gastrointestinal symptoms and there was no overall difference between the two groups. The adverse effects noted included epigastralgias, nausea, diarrhoea, taste loss and haemorrhoids.

1. Mohanty K et al. Evaluation of efficacy and safety of erdosteine in patients affected by exacerbation of chronic bronchitis and receiving ciprofloxacin as basic treatment. Journal of Clinical Research 2001: 4; 35-39.
2. Marchioni C et al. Evaluation of efficacy and safety of erdosteine in patients affected by chronic bronchitis during an infective exacerbation phase and receiving amoxicillin as basic treatment (ECOBES, European Chronic Obstructive Bronchitis Erdosteine Study). International Journal of Clinical Pharmacology and Therapeutics 1995: Vol 33 (11) : 612-618.

Further information: Galen 028 38334974

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