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Research Probes Efficacy, Safety of Inhaled Insulin

Janice Simmons

In separate clinical trials, long-term use of inhaled insulin appeared to show safe and effective glycemic control while increasing patient satisfaction and quality of life, according to presentations at the American Diabetes Association's (ADA's) Scientific Sessions in Orlando, Fla.

These data indicate that inhaled insulin may have the potential to get the green light to be marketed and sold in the United States—but how soon remains to be seen.

Pfizer, Aventis, and Nektar Therapeutics, the companies behind one of the more publicized inhaled insulin products, Exubera, are reportedly almost ready to file a New Drug Application with the Food and Drug Administration, but sources would not say when that will occur. In March, the companies filed an application with the European Medicines Evaluation Agency to seek approval to market Exubera to adult patients.

One of the key issues that needs to be addressed with Exubera is safety, particularly its effect on pulmonary function. At the ADA meeting, University of Miami researcher Jay Skyler, MD, presented results of a clinical trial showing that the efficacy and safety observed with inhaled insulin in 3-month trials could be maintained during 4 years of continuous therapy.

A "small but clinically insignificant drop" was observed in some of the airways tests, said Anthony Barnett, MD, the lead study investigator for Exubera. The study showed that "certainly for the length of time, this appears to be a very safe agent." Ongoing clinical trials show that inhaled insulin "really does improve glycemic control in patients who are not getting to target with either single oral treatment or dual therapy," Barnett said. From an efficacy point of view, "it would appear to be as good as subcutaneous insulin injectables," and from a patient satisfaction point of view, there appears to be "incredibly high patient acceptability."

What is likely to appeal to patients about inhaled insulin is that it can be used "relatively unobtrusively" by patients with diabetes before a meal, said Wayne Wendell Cheatham, MD, who is senior vice president for medical and regulatory affairs for MannKind Corp. in Danbury, Conn.

MannKind has developed the Technosphere Insulin System, which uses a handheld device the size of a pager. Currently in Phase IIb clinical trials, MannKind is looking to replicate a "first-phase insulin response," Cheatham said.

This means it "provides a capability of disposing the sugar that comes from the meal that is being eaten," he added.

"This is important because it is a relationship that has never before been available with a therapy for diabetes," Cheatham said. Bringing this system to the market if clinical trials are successful would take some time—possibly until late 2007 or early 2008, he noted.

Other companies looking at inhaled insulin are Eli Lilly and Co., in collaboration with Alkermes; and Novo Nordisk, in collaboration with Aradigm Corp.

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Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Simmons, J. Search for Related Content PubMed Articles by Simmons, J. Social Bookmarking                What's this?