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This is a revised version of this press release, originally issued Jan. 27, 2006.
The release was revised to clarify recommendations for baseline tests.
FDA News
FOR IMMEDIATE RELEASE
P06-13
January 27, 2006
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes
There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration's approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.
"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."
Diabetes is a disease that affects the amount of insulin and sugar in your body. Exubera is a human form of insulin and as such, lowers blood sugar concentrations by allowing the blood sugar to be taken up by cells as a source of fuel. Exubera is a powdered form of insulin that is able to be inhaled into the lungs through the patient's mouth using a specially designed inhaler.
There are two major types of diabetes -- type 1 and type 2. People with type 1 diabetes produce virtually no insulin. In type 2, the most common form of the disease, the body does not produce enough insulin or effectively use insulin. If people with diabetes do not properly control their blood sugar levels, serious complications including heart disease, kidney failure, blindness, and nerve damage may develop.
The safety and efficacy of Exubera have been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. In clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by an injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera inhaled insulin compared to 105 minutes (range 60 to 240 minutes) with regular insulin, respectively. In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes, inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood sugar, or with longer acting insulins.
Exubera prescriptions will be accompanied by a Medication Guide containing FDA-approved information written especially for patients. Pharmacists are required to distribute Medication Guides with products FDA has determined are important to health, and patient adherence to directions for use is crucial to the product's effectiveness. Patients are advised to read the entire Medication Guide and talk to their healthcare provider if they have further questions.
Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly. Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth.
Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended after the first 6 months of treatment and every year thereafter, even if there are no pulmonary symptoms.
While Exubera has been extensively studied for safety, the sponsor has committed to performing long-term studies to confirm the continued safety of Exubera after it is marketed and to examine more thoroughly the issue of the efficacy and safety of Exubera in patients with underlying lung disease.
Exubera is manufactured by Pfizer Inc., NY, NY.
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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.