Exubera Inhaled Insulin Expected to be Available Soon for Diabetes Treatment

January 27th 2006

Exubera Inhaler

The Food and Drug Administration (FDA) approved the first inhaled form of insulin on Friday. This method of intake is easier than injections and gives millions of adult diabetics an alternative to the older form of administering insulin. Americans can expect to see this on the market by midyear.

Exubera, developed by Nektar Therapeutics, is a powder form of recombinant human insulin (rDNA) for treating adults with type 1 and type 2 diabetes. According to an FDA press release, this is the first “insulin delivery option introduced since the discovery of insulin in the 1920s.”

Dr. Steven Galson, Director of the Center for Drug Evaluation and Research for the FDA said "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."

Exubera is a human form of insulin and lowers blood sugar concentrations by allowing he blood sugar o be taken up by cells as a source of fuel. The patients inhale the drug using a specially designed inhaler. It is important to control diabetes to avoid serious complications including heart disease, kidney failure, blindness, and nerve damage.

Since the insulin is inhaled it reaches the blood stream very quickly, in fact according to the FDA “more quickly than some insulins, called regular insulin, administered by an injection.” Peak insulin levels were reached using Exubera between 30 and 90 minutes with most patients peaking in 49 minutes. This compares to 60 to 240 minutes (most in 105 minutes) using regular insulin. According to the FDA “In type 1 diabetes, inhaled insulin may be added to longer acting insulins as a replacement for short-acting insulin taken with meals.”

For people with type 2 diabetes, the inhaled insulin may be used alone, along with non-insulin oral pills that control blood sugar, or with longer acting insulins. Be sure to read the Medication Guide containing FDA approval information first. Low blood sugar can occur with the use of the product. It is important to monitor this.

There may be some side effects including cough, shortness of breath, sore throat, and dry mouth. Do not use the drug if you smoke or have quit within the last 6 months. It is not recommended for patients with asthma, bronchitis, or emphysema. According to the FDA, baseline tests for lung function are recommended before beginning treatment and are recommended to be repeated every 6 to 12 months thereafter.

Pfizer, the worlds largest drug company, will pay Nektar a royalty of 15 percent on sales, according to the New York Times. There is no price set for Exubera yet, but analysts expect the drug to cost “two or three times as much as injected insulin”.