Inhaled Insulin Gets FDA OK

Editor's Note: In October 2007 the drug company Pfizer said it was halting sales of Exubera because of financial reasons.

Jan. 27, 2006 -- Exubera today became the first inhaled insulin to get FDA approval.

It will be on pharmacy shelves by the middle of the year, says Rebecca Hamm, spokeswoman for Exubera maker Pfizer.

Exubera delivers short-acting insulin via an inhaler. It offers adults with type 1 or type 2 diabetes an alternative to the insulin injections they need to control their blood sugar. The device is not approved for use by children younger than 18.

The FDA approval requires the manufacturer to distribute medication guides along with Exubera. The guide contains FDA-approved information written especially for patients.

Exubera is not to be used by smokers or people who have quit smoking within the previous six months. It's also not recommended for people with asthma, bronchitis, or emphysema. However, people with colds or flu should still be able to take the drug, although it may cause coughing.

The FDA recommends that patients get tested for good lung function before beginning Exubera treatment. These tests should be repeated six months and 12 months after starting treatment, and every 12 months thereafter.

The device has been in development for 10 years in a joint effort by Pfizer, Sanofi-Aventis, and Nektar Therapeutics. Earlier this month Pfizer bought Sanofi-Aventis' rights to Exubera. Pfizer and Sanofi-Aventis are WebMD sponsors.

"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research, says in a news release. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."

The Exubera device isn't as small as an asthma inhaler. Folded up, it's the size of a standard flashlight. A retractable inhaler tube comes out from the body of the device; when extended it reaches from the chest to the mouth. A blister pack of insulin then must be inserted before the device is triggered. Patients and doctors will get extensive training on how to use Exubera.

Why Inhaled Insulin?

Insulin is made by a small organ called the pancreas. Insulin is an essential hormone that regulates how the body uses sugar, the fuel that feeds every cell in the body. People with diabetes can't make enough insulin to keep their blood sugar under control.

The discovery that insulin could be given to people with diabetes was one of the great medical breakthroughs of all time. Long-acting forms of insulin keep blood sugar under control throughout the day. However, many people with diabetes need more insulin with meals to cope with the spike in blood sugar caused by eating. They also need this insulin to wear off quickly so they don't have a blood-sugar crash when the meal is over.