Exubera® -: Treatment of type 1 and type 2 diabetes

Exubera(R) is an inhaled insulin formulation for patients with type 1 and insulin-requiring type 2 diabetes, the most advanced of several inhaled insulin systems being developed. It uses an inhalation device and inhaled insulin formulation process that is a non-invasive alternative to injections. Exubera(R) is associated with fewer systemic side effects and offers rapid symptom relief. The formulation has been studied in over 3,000 patients, some for as long as 6 years. Evidence suggests that Exubere may be as effective as s.c. insulin and superior to oral agents in controlling glycemia in patients with diabetes. It appears to have a unique effect on both fasting plasma and 2-h postprandial glucose levels compared with other treatment regimens. The increased insulin antibodies that appear with Exubere are not associated with any significant clinical manifestations. In clinical trials, the frequency and severity of adverse events were similar in the Exubere and control groups. Although mild to moderate cough occurred more frequently in Exubera(R)-treated patients, it disappeared with increased exposure. A small difference in pulmonary function tests, without clinical manifestations, has been observed between Exubera(R) and control patients. Exubere has been filed for approval in Europe and is expected to be submitted soon to the FDA.