FDA approves therapeutic use of insulin inhalant

January 28, 2006

The United States Food and Drug Administration (FDA) approved the use of an inhalable form of insulin for treating both forms of diabetes in adults. The product, manufactured by Pfizer Inc. is called Exubera and is a inhaled powder form of recombinant short-acting human insulin (rDNA).

Insulin is a hormone produced by the pancreas that, when released into the blood, controls the upper limits of glucose presence in the bloodstream. Diabetics cannot produce (enough) insulin on their own, and have to control their blood sugars by appropriate diet, exercise and medication. Untreated Diabetes can have a serious adverse effect on health, it can lead to higher risk of cardiovascular disease, kidney failure, retinal damage and diabetic shock, which can be fatal. Insulin has been used for the treatment of diabetes for many years now, but some patients find it difficult (and costly) to use as it has to be injected into the body, usually several times a day. Currently, about five million Americans take insulin injections. Also, the use of any form of insulin can cause blood sugar to drop below safe levels, a condition called hypoglycemia. As a result, the use of insulin must be accompanied by a careful and regular monitoring of blood sugar levels.

The FDA has issued guidelines that the inhalable form should not be used by smokers, patients with asthma, bronchitis, or emphysema as tests have shown that its use can reduce the breathing capacity of the lungs. Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth. The FDA has given its approval on the basis of safety studies of short-term use and studies of its effects over long-term use are underway.

Pfizer has said the product wouldn't be widely available until June or July and that exact prices haven't been set. A Pfizer spokesperson has said that the price will be "competitive" to injected insulin.