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Company to Stop Selling Inhaled Insulin

Oct. 26 (iVillage Total Health) – Poor sales may mean the end of Exubera, the first and only brand of inhaled insulin available.

Marketed by Pfizer Inc., the product was launched only last summer, after years of research and publicity. Inhaled insulin had been described by the U.S. Food and Drug Administration as the biggest advance in insulin therapy since insulin’s discovery in the 1920s.

However, some patients and doctors have complained that the oral inhaler was too big and inconvenient and that insurance companies resisted covering the recommended periodic lung tests. And some patients reported being embarrassed to use the device in public because of its resemblance to a “bong” – a device used to smoke marijuana.

Pfizer announced last week that it would quit selling Exubera in three months. It suggested that doctors begin moving their patients to other diabetes medications. The company emphasized that the drug was safe and effective, and urged patients not to stop taking it on their own. Patients with questions may contact their physician or call the toll-free number for Exubera: 800-398-2372.

Inhaled insulin was developed in conjunction with a company called Nektar Therapeutics. Nektar, based in San Carlos, Calif., expressed disappointment in Pfizer’s decision, noting in a statement that “We continue to believe Exubera is an important advancement for diabetic patients.”

Nektar indicated it might seek another marketing partner so that the drug could remain available, according to the company’s filing with the Securities and Exchange Commission. However, in its filing, Nektar indicated it would have to seek FDA approval once more to manufacture the drug – a difficult and time-consuming process.

Other companies are developing brands of orally and nasally inhaled insulin, including forms involving a smaller inhaler that might find greater acceptance. Additional noninvasive methods of insulin administration being researched include pills and skin patches.

All people with type 1 diabetes and some people with other forms of diabetes must take insulin to survive. Insulin is a hormone (messenger chemical), normally produced in the pancreas, that lets the body use glucose (blood sugar) for energy. Syringe injections remain the most common method of delivering insulin therapy.

According to the FDA, clinical trials involving about 2,500 diabetic volunteers found Exubera to be safe and effective. The FDA approved it for nonsmoking adults with type 1 diabetes or type 2 diabetes who do not have asthma, bronchitis or emphysema. Some people using the drug, including anyone with type 1 diabetes, still need to inject long-acting insulin.

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