Inhaled Insulin Approved
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FDA Approves Inhaled Insulin
As recently reported by medscape, the first inhaled insulin (Exubera) was finally approved on February 7, 2006 by the FDA for adult patients with type 1 and type 2 diabetes. Exubera represents the first new delivery method for insulin since it was first discovered in the 1920's. Pfizer Inc will market Exubera. It was co-developed by Pfizer and Sanofi Aventis, but Pfizer recently bought the rights to Exubera from Sanofi Aventis.
There are some restrictions on the use of Exubera. According to the FDA, smokers or people who have quit smoking within the previous 6 months are not eligible for Exubera. Also, patients with asthma, bronchitis, or emphysema are not recommended to use Exubera.
However, people with colds or other upper respiratory infection should still be able to take the drug, although it may cause coughing. The FDA is also recommending pulmonary function testing for all patients prior to and every 6 to 12 months after they start Exubera.
The device that administers the insulin is much larger than an asthma inhaler. When the device is folded up it is similar in size to a standard flashlight. Both doctors and patients will need to be trained on how to use the new device.
Exubera has been approved for treatment of both type 1 and type 2 diabetes. However, clinical trials found that fewer than 30% of people with type 1 diabetes were able to reduce their blood sugar to recommended levels after 6 months of treatment with the inhaled insulin.
The State of Diabetes
The diabetes population in the United States continues to grow each year. Estimates have the incidence of diabetes affecting from 100-300 million people over the next decade. The increase in type 2 diabetes has a direct link to the incidence of obesity in the United States. People, who feel they are at risk for type 2 diabetes, should maintain a low fat diet, and participate in daily exercise. Simple life-style changes like this can reduce the chances of becoming diabetic. It is important to consult your primary care doctor prior to starting any new exercise regimen.