FDA Approves First Form of Inhaled Insulin
A long-awaited alternative to insulin injections soon will be available to millions of people with type 1 and type 2 diabetes with the Food and Drug Administration's (FDA) January 27 approval of an inhaled powder form of recombinant human insulin (Exubera, Pfizer).
“Until today, patients with diabetes who need insulin to manage their disease only had one way to treat their condition,” says Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research, in a release. “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”
Exubera was tested for safety and efficacy in about 2,500 adult patients with type 1 and type 2 diabetes, according to an FDA release. In those studies, the time to reach peak insulin concentration was faster for Exubera than for injected insulin—49 versus 105 minutes.
The Exubera inhaler weighs about 4 oz and is about the size of an eye-glasses case when closed, according to Pfizer.
“The device is a little too cumbersome to be used in multiple daily therapies like we use in type 1 diabetes, but certainly that would be an option,” says John Buse, MD, PhD, CDE, associate professor of medicine and director of the Diabetes Care Center at the University of North Carolina in Chapel Hill. “It's mostly going to be used in the type 2 population that's just getting started in the insulin business.”
For patients with type 2 diabetes, inhaled insulin can be used as an alternative to rapid-acting insulin injections or diabetes pills or in combination with longer-acting insulin and pills. For patients with type 1 diabetes, Exubera should be used in combination with longer-acting insulin.
NEEDLE RELIEF
“Many people who could benefit from insulin are fearful of injections, so they delay treatment 5 years or 10 years, placing them at risk for serious complications,” says William Cefalu, MD, Exubera investigator and chief of the division of nutrition and chronic diseases at the Pennington Biomedical Research Center in Baton Rouge, La. “Now, for the first time, patients can improve blood sugar control with fewer or no painful injections.”
So, will more patients be willing to initiate insulin therapy with this new option?
“I think it's going to have a modest benefit in that regard,” Buse says. “There are some people who really are needlephobic. [Inhaled insulin] will help.
“I can imagine its being used in patients as their introduction to insulin, that someone would take it with their biggest meal of the day, or that someone who is failing long-acting insulin preparations might take it as a puff of insulin with their biggest meal or perhaps with two meals a day,” Buse says.
PATIENT SAFETY
Buse says potential problems with any insulin are weight gain and hypoglycemia, but that inhaled insulin still will be an advantage for some patients. “We have to wait for the package insert to really know who those people will be,” Buse says.
Exubera prescriptions will include a Medication Guide with FDA-approved information for patients. The FDA advises patients to read the entire guide and discuss any questions with their care provider. Patients also should closely monitor blood glucose levels to help prevent hypoglycemia.
Other possible side effects of Exubera treatment are cough, shortness of breath, sore throat, and dry mouth. Patients who smoke or have quit smoking within 6 months should not use this drug, and it is not recommended for those with asthma, bronchitis, or emphysema. Baseline and biannual lung-function tests are recommended for all patients prescribed inhaled insulin.
Pfizer says Exubera will be available for prescription this summer and costs will be on par with those of injectable insulin. Pfizer developed the drug over 10 years with Sanofi-Aventis and Nektar Therapeutics. The drugmaker has committed to long-term post-marketing studies to track Exubera's continued safety and efficacy, particularly in patients with lung problems. ▪
