First dry powder inhalation antibiotic for cystic fibrosis
world's first dry powder inhalation system for antibiotics, is now
conducting phase III trials on a new dry powder antibiotic
formulation which promises to change the lives of cystic fibrosis
sufferers by drastically reducing the daily treatment time.
The UK company is using a dry powder formulation of its existing antibiotic Colomycin (colistimethate sodium) in the new inhalation system called Colobreathe, for use by cystic fibrosis patients whose lungs are infected by pseudomonas aeruginosa bacteria.
The new drug delivery system will be small, resembling a pen, and uses an existing spring-loaded delivery device to distribute the contents of an antibiotic capsule when the patient inhales.
Currently patients with cystic fibrosis require the use of a nebuliser twice a day to administer their antibiotic medication, involving complex equipment and drug reconstitution, an encumbering process that can take 20-30 minutes each time.
"Our new system will reduce this total process down to a maximum of two minutes," Dr Martin Goldman, senior medical advisor, >Forest Laboratories, told In-PharmaTechnologist.com.
Because cystic fibrosis is primarily a disease of younger people, having to use a timely nebuliser is a main cause of patients not taking their medication regularly or properly. Thus a new method that can decrease the burden of treatment and offer these patients more freedom is highly sought after.
In fact, the whole market for respiratory medicines is shifting towards dry powder inhaled therapies that offer patients more convenience and more effective drug delivery, Goldman explained.
Cystic fibrosis is the most common lethal genetic disease in Caucasians, affecting about one in every 2,000, and causes the accumulation of thick and infected secretions in the lungs. These eventually lead to respiratory failure and an early death and people with cystic fibrosis have a life expectancy of just 30 years.
Pseudomonas aeruginosa is the most common pathogen causing these infections, and the vast majority of people with cystic fibrosis become chronically colonised with the organism.
Colomycin works by disrupting the structure of part of the bacterial cell membrane, causing the vital contents of the bacteria to leak out and eventually the death of the bacteria. This unique mode of action has meant that development of resistance is almost non-existent.
Forest Laboratories currently holds 80 per cent of the market in the UK and Ireland with its nebuliser version of Colomycin and expects its new inhaled product to capture a significant share in the European market.
"Although it will be more expensive than our nebuliser version, the new inhalation system it will still cheaper than TOBI (tobramycin), the only other licensed nebuliser system for cystic fibrosis on the European market," said Goldman.
Because of its combined convenience of use and lower antibiotic resistance potential, Forest Laboratories' new formulation has now been granted orphan drug status by the European Medicines Evaluation Agency.
While still relatively uncommon, experience with other products has shown that products for treating opportunistic infections in cystic fibrosis can achieve reasonable revenues, as well as providing significant benefits to the patients.
Chiron is also now working on an inhaled version of its antibiotic, TOBI (tobramycin) and Bayer is collaborating with Nektar on the development of a dry powder inhaled formulation of its antibiotic, Cipro (ciprofloxacin).
However, Forest Laboratories is ahead of the game, with a multi-centre phase III clinical trial designed to confirm the efficacy of Colobreathe already underway in major cystic fibrosis centres in Europe, called the 'Freedom Study'.
The company is planning to expand the 'Freedom Study' during the next 12 months in up to 70 centres across Europe and expects Colobreathe to be available on the European market after 2007.
Dr Jane Davies of the Royal Brompton Hospital, London, who has participated in early studies of Colobreathe, said, "Early indications are that patients find this dry powder inhalation system easier to use, and preferable to the conventional nebuliser systems that they currently use to inhale antibiotics."
"All indications are that cystic fibrosis 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 with cystic fibrosis who can spend several hours a day administering their treatments using a powered nebuliser," said Davies.
The mother of one teenager in the study said that the product had allowed her son the freedom to spend the night at a friend's house for the first time in his life, said Goldman.
