WASHINGTON -- Pfizer (PFE - Get Report) said Saturday that its inhaled insulin, Exubera, will be available in the U.S. starting in mid-July. Although the drug had been approved by the Food and Drug Administration in January, the company previously said it would take some time to develop an education program for doctors and patients before putting the drug on the market.Pfizer made the announcement at the annual scientific meeting of the American Diabetes Association in Washington, D.C. However, the company didn't announce a price for the drug, which Pfizer and its partner, Nektar Therapeutics ( NKTR - Get Report), have been touting as more convenient that injectable insulin. Exubera also has been approved by the European Union. It is being sold in Germany and Ireland, and Pfizer said it expects diabetics in the United Kingdom to gain access soon. The drug is approved in the U.S. and foreign markets for treating both Type 1 diabetes and Type 2 diabetes. The former accounts for about 5% of all cases and is caused by the body being unable to make insulin that turns sugar into energy. Type 2 diabetes results from the body being unable to properly use insulin. This disease is often associated with obesity, aging, physical inactivity and genetics. In the U.S., Exubera can be used by Type 2 patients with blood-sugar control pills or with longer-acting insulin. In Type 1 patients, Pfizer says the drug should be used in combination with longer-acting insulin. "Many people with Type 2 diabetes are reluctant to start treatment with injected insulin," Pfizer said Saturday. "A review of medical databases in the U.S. and the U.K. shows that many delay insulin use for at least four years or more." Pfizer plans to present more details Monday on its claim that many patients now taking injected insulin would consider switching to inhaled insulin.
Pfizer also released results of two late-stage clinical trials which it says reinforce previous research that Exubera is safe and effective for both Type 1 and Type 2 diabetes. Exubera is a rapid-acting insulin in dry power form that is inhaled through the mouth via a device developed by Nektar. It is used before eating. Researchers said Saturday that Exubera provided "sustained blood sugar" control over two years. When compared against injected insulin, Exubera users gained about half as much weight as did users of injectable insulin. These results "confirm that people who switched from rapid-acting injectable insulin to Exubera experienced no loss of blood sugar control," said Dr. Julio Rosenstock, lead investigator from the Dallas Diabetes and Endocrine Center and clinical professor of medicine at the University of Texas Southwestern Medical Center in Dallas. In a study of Type 2 patients, researchers found that Exubera patients exhibited similar improvements in blood sugar levels vs. injectable insulin patients over two years. Exubera patients gained 3.7 pounds while injectable insulin patients gained 6.6 pounds. One key test for Exubera will be if it causes any lung problems. In this study, researchers said that average decreases in lung function among Exubera users vs. other patients "were small, occurred early, did not progress and showed resolution shortly after discontinuation of therapy." Patients shouldn't take Exubera if they have poorly controlled or unstable lung disease, if they smoke or if they have stopped smoking less than six months before starting Exubera. Patients are told to get a lung-function test before they start taking the drug; Pfizer says these patients should be re-checked after six months and then yearly thereafter. Pfizer notes that some patients have reported a mild cough while taking the drug, which occurred quickly after patients inhaled the drug. "Coughing occurred less frequently as patients continued to use Exubera," the company says. In a similar test of Type 1 diabetes patients, researchers reported Saturday Exubera patients gained an average of 1.7 pounds during the two-year study while injectable insulin users gained 4.4 pounds. The lung-function results were similar to those patients in the Type 2 study. And like the Type 2 study, these researchers found that side effects were similar between Exubera and injectable insulin except for coughing, which was more frequent for the Exubera users. "The cough was defined as mild, occuring shortly after dosing and rarely resulted in discontinued treatment," said Pfizer, referring to both the Type 1 and Type 2 studies.