Pfizer added muster to its inhaled insulin product Exubera yesterday after new data unveiled at the European Association for the Study of Diabetes showed it was well-tolerated and efficacious across 14 Phase II and III clinical trials in type 1 and 2 disease, as well as in diabetics who developed respiratory infections. The US giant is clearly hoping the new data will help contain any lasting jitters that Exubera could have a negative impact on lung function.

Said Professor Philippe Camus, lead investigator from the University Medical Center: "It shows that the efficacy and tolerability of Exubera remain unchanged even if patients develop a cold or the flu. Also, studies showed patients taking Exubera are no more likely to develop a respiratory infection than patients using injectable insulin."

And it is clearly hoping an analysis of earlier data, showing patients with uncontrolled disease are twice as likely to choose Exubera therapy over conventional insulin (44% versus 17%), will help convince healthcare professionals they are more likely to get patients onto treatment if they prescribe inhaled over injectable insulin. “If Exubera can get more people to accept insulin at all and to accept it earlier than they ordinarily might, we would expect that more people could get their blood sugars under control," said Professor Nick Freemantle, professor of clinical epidemiology and biostatistics from the University of Birmingham, UK.

And another plus point for Exubera was the reduced risk of weight gain compared to injectable insulin. Type 2 patients gained 0.7kg with Exubera versus 1.6kg for those patients given injectable insulin, while the difference was even greater for type 1 patients (0.2 kg with Exubera vs 1.1 kg with injected insulin). Weight gain is of particular concern in diabetes as obesity tends to go hand in hand with the disease and can heighten the risk of serious complications, including heart disease.

Exubera is currently available in the USA, the UK, Ireland and Germany. However, Pfizer is having a hard job in convincing cost-effectiveness bodies that health services should pay more for inhaled insulin; the UK’s National Institute for Health and Clinical Excellence recently recommended Exubera only for diabetics who had demonstrated a phobia of needles, while the Scottish Medicines Consortium this week gave a resounding no to its use. Pfizer is due to launch Exubera in the USA this month, having pushed it back from July.