FDA Panel Greenlights Diabetes Inhaler

Friday, 9 September 2005, 21:00

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.

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.

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One Comment for “FDA Panel Greenlights Diabetes Inhaler”

  1. 1AmyT of www.diabetesmine.com

    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?