FDA Panel Greenlights Diabetes Inhaler
A Food and Drug Administration advisory panel has recommended approval of a new insulin delivery system in which the substance would be inhaled rather than injected with needles.
The panel voted 7-2 to approve Exubera for treatment of both juvenile and adult-onset diabetes. The FDA is expected to follow the recommendation.
Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device, has been studied in more than 3,500 patients, some for over seven years. The companies seek approval to market Exubera for adult patients with type 1 and type 2 diabetes.
Category : Diabetes | Tags :Results from Phase 2 trials of the inhaler were presented at the June, 1998, American Diabetes Association Convention in Chicago. These studies involved 70 people with Type 1 diabetes and 51 people with Type 2 diabetes. Researchers found blood sugar control was equivalent when inhaled Regular insulin was compared to injected Regular taken before each meal.
1AmyT of www.diabetesmine.com
wrote on 10 September 2005 at 7:48
Hey Jo,
Exciting, yes, but I read that we’ll have to inhale 7x as much as we’d normally inject. The whole dosing issue seems problematic, no?
(Oh, and how come I’m not in your blogroll anymore?