A pooled analysis of three studies involving over 680 adults with type 2 diabetes showed that participants who added Exubera to their treatment regimen maintained glycemic control over a two-year period and experienced no clinically important effects on pulmonary function compared to patients treated with oral agents alone.
A fourth study showed that three months of Exubera was well tolerated and as effective as injected insulin in achieving tight glycemic control in adults with type 1 diabetes.
Dr William Cefalu, lead study investigator and professor at Louisiana State University said: “Innovative new therapies are needed to encourage earlier use and acceptance of insulin, and these results suggest that Exubera may be a promising treatment option for people with diabetes.”
The product of a joint-development program between the Sanofi-Aventis and Pfizer, Exubera is a mealtime insulin that is inhaled through the mouth into the lungs prior to eating, using a proprietary inhalation device developed by Nektar. Exubera has been submitted for approval in the US and the Europe for the treatment of both type 1 and type 2 diabetes in adults.
Pending approval, Exubera would represent the latest innovation in insulin delivery and would be the first non-injectable option available in the US and Europe since the discovery of insulin.
Eli Lilly, working in collaboration with Alkermes, has also produced an insulin product for inhalation. However, the Lilly formulation is far behind Pfizer’s Exubera in terms of development. As yet no drug application has been submitted by Lilly.