Forest Laboratories re-formulates cystic fibrosis antibiotic
In what it believes to be a world first, Forest Laboratories UK has developed a high-payload dry powder inhalation system for antibiotics.
In what it believes to be a world first, Forest Laboratories UK has developed a high-payload dry powder inhalation system for antibiotics.
It is using the system for the administration of a dry powder inhalation formulation of Colomycin (colistimethate sodium), its antibiotic for cystic fibrosis (CF) patients whose lungs are infected by Pseudomonas Aeruginosa. The new formulation has been granted orphan drug status by the European Medicines Evaluation Agency (EMEA).
The 'Freedom Study', a multi-centre Phase III clinical trial programme designed to confirm the efficacy of Colobreathe (colistimethate sodium) is currently underway in Europe. Measuring lung function, microbiological resistance and quality of life, the company is aiming to perform the trial in up to 70 European countries.
Colomycin, a polymyxin, works by disrupting the structure of part of the bacterial cell membrane, causing the vital contents of the bacteria to 'leak out', which results in the eventual death of the bacteria. Such a mode of action means that development of resistance is 'almost non-existent'.
'Early indications are that patients find this dry powder inhalation system easier to use, and prefer-able to the conventional nebuliser systems that they currently use to inhale antibiotics,' said Dr Jane Davies of the Royal Brompton Hospital, London, UK. 'In fact, all indications are that CF patients will be able to inhale a full dose of antibiotic treatment in a matter of seconds. We are hopeful that this new presentation of a very well established and proven antibiotic will decrease the burden of treatment for patients who can have to spend several hours a day administering their treatments using a powered nebuliser.'
At a recent meeting of investigators in Paris, France, Professor Gerd Doring of the University of Tubingen, Germany, and president of the European Cystic Fibrosis Society, reminded the audience of the importance of developing new antibiotics for the treatment of pulmonary infection in CF, saying that it was 'the responsibility of physicians to participate in trials that would bring new treatments to patients'.
