Diabetes Current Topics in Diabetes

Inhaled Insulin Passes FDA Review

Sept. 8, 2005—An advisory panel for the Food and Drug Administration (FDA) approved the first-ever inhaled form of insulin today, providing a new option for people with diabetes who have never quite taken to insulin shots. The expert panel voted 7-2 to approve the new insulin device, known as Exubera, for patients with either the type 1 or type 2 form of the disease. The FDA must still formally approve Exubera, but it usually follows the advice of its committees.

Unlike traditional insulin, Exubera is a dry powder that is breathed in through an aerosol spray, similar to the inhalers used by asthma patients. This type of therapy is short-acting, meaning that Exubera must be taken before meals to control a spike in blood sugar.

Most diabetes patients, even with inhaled insulin, will need to continue nightly injections to provide long-term control. Still, there is little doubt that many would welcome even the slightest break from shots.

"I think it will be popular," says Dr. Simeon Margolis, a diabetes specialist at Johns Hopkins University in Baltimore.

Waiting to Exhale
Concerns, however, have been raised about the long-term safety of breathing in such a powerful medicine.

Studies show a slight risk of lung damage from Exubera compared to other diabetes drugs. But data presented to the advisory panel suggested that the side effects are reversible and not that serious.

Pfizer, the company that is marketing Exubera, announced that they will follow patients who take the drug for up to 15 years.

Some experts are concerned about the potential damage to the lungs that may show up later, but published studies suggest that Exubera is safe and equally effective in treating diabetes compared to injecting insulin, at least over the short term. In one trial of nearly 300 people with type 1 diabetes, researchers found that both forms of insulin lead to long-term blood sugar control, with Exubera showing better reductions after meals.

The main side effect of insulin adminstration was coughing, which was significantly more common in those who used inhaled insulin. Other studies have found equally positive results in type 2 diabetes.

Convenience Versus Shots
Although insulin is mostly used to treat type 1 disease, doctors are finding an increasing need for better blood sugar control in type 2 patients, prompting a growing number of people to rely on insulin shots.

When volunteers in studies were asked what they preferred—shots or inhaling insulin—most picked the inhalant. Yet, while more convenient than shots, inhaling insulin could have its own difficulties, says Margolis.

He is concerned that some people may not correctly breathe in the insulin, a problem that asthma patients typically face with inhalers. But there is a huge difference, Margolis says, in coming up short on asthma medications versus failing to get enough insulin.

Poorly controlled diabetes can lead to heart disease, kidney problems and even blindness.

"You had better be pretty darned good at using this," he says of those who might one day use an insulin inhaler.