FDA Approves Inhalable Insulin Exubera

By Linda Orlando

The Food and Drug Administration today announced approval of the first new way of delivering insulin since the discovery of insulin in the 1920s. The new version of insulin is inhalable, and can be used by adult diabetics as an alternative to some of the regular injections that have been used for decades. The drug, called Exubera, is a powder that can be inhaled into the lungs (pulmonary insulin) using a specially designed inhaler.

The concept of delivering insulin directly to the lungs was first considered in 1925, but the technical problems in developing such a treatment were hard to overcome. Insulin inhaled through the mouth usually gets deposited mostly in the pharynx, without reaching the lungs. But Pfizer and Aventis, the manufacturers of the drug, formed an alliance with Nektar Therapeutics, a company whose specialty is developing delivery solutions for administering pulmonary versions of drugs. The result of that collaboration is Exubera.

Over 2,000 patients received Exubera in clinical trials worldwide, some for as long as five years. Results from the clinical trials already suggest that the drug may be just as effective as insulin injections for lowering blood glucose in diabetic patients, and even more effective than oral medications. Besides improving the quality of life for both Type 1 and Type 2 diabetics, inhaled insulin enters the bloodstream more quickly—which can be especially beneficial when insulin must be administered just before meals. The ease of administration may also persuade injection-reluctant patients to comply with the treatment and use insulin more regularly to control their diabetes.

Daily injections, sometimes more than once a day, has always been a major drawback for diabetics because administering the drug interferes with daily activities and travel. Although there are special self-injection pens available that make injections easier than needles, they do not take the place of regular injections. Various alternatives to hypodermic injections have been investigated in the past, including insulin patches, insulin pumps, and a bevy of oral formulations, but Exubera is the first inhalable insulin to be approved by the FDA for use by the general population.

According to the manufacturer’s website (http://www.pfizer.com), side effects of Exubera may include low blood sugar, cough, shortness of breath, sore throat, and dry mouth. The drug should not be used by people who smoke or have quit smoking within the last six months, and it is not recommended for patients with pulmonary diseases such as asthma, bronchitis, or emphysema. According to the FDA, the use of Exubera will not totally replace the need for diabetics to occasionally inject insulin, and diabetics will still have to prick their fingers to check their blood sugar levels. But Exubera has already improved the lives of diabetic patients in Europe, and with the FDA’s approval, now American patients will be able to benefit as well. Patients and health care providers can call 1-800-EXUBERA and register to receive more information about Exubera when it is available.