Non-Injectable Insulins Win Approval: Pfizer in the US, Generex in South America

With a Feb. 1 US Food and Drug Administration (Rockville, MD, www.fda.gov) approval, Pfizer’s (New York, NY, www.pfizer.com) “Exubera” (insulin human [rDNA origin]) inhalation powder to treat adults with type 1 and type 2 diabetes became the first inhaled insulin okayed for marketing in the United States, but the second marketed worldwide. Last November, Generex’s (Toronto, Ontario, Canada, www.generex.com) oral insulin “Oral-lyn” went on the market in Ecuador for the treatment of patients with Type-2 diabetes, and is in clinical trials in Europe.

United States Approval

Exubera was found to be an effective substitute to injectable insulin and can be taken with oral insulin. Plans are underway to make the drug available by mid-year.

Said Hank McKinnell, chairman and chief executive officer of Pfizer in a release, "Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease."

According to Pfizer, Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs prior to eating, using the handheld Exubera Inhaler. Weighing four ounces, the inhaler produces a cloud of insulin powder, which is designed to pass rapidly into the bloodstream to regulate the body's blood sugar levels.

“During clinical trials, Exubera was studied in more than 2,500 adults with type 1 or type 2 diabetes for an average duration of 20 months. In clinical trials, many patients using Exubera reported greater treatment satisfaction than patients taking insulin by injection,” Pfizer said.

The drug does have a few drawbacks. Smokers or people who quit smoking within six months cannot use the drug. Anyone suffering from chronic or poorly controlled lung disease also is not a candidate from treatment. Side effects reported include low blood sugar levels and a mild cough after inhalation.”

Going Global

Meanwhile, biotech company Generex is planning on releasing Oral-lyn in the rest of South America by the end of the year. Unlike Exubera, Oral-lyn is delivered to the mouth for absorption through the buccal mucosa. The drug, which is delivered through the company’s RapidMist inhalation system, is expected to have sales close to $300 million, according to Generex.

The company has met with Health Canada officials to discuss filing a new drug submission to market and distribute Oral-lyn in Canada. There is no word yet as to when or if the Generex will file for a US new drug application for FDA approval.

Correction: The title of this article, as printed in the Feb. 2, 2006 ePT, was incorrect. The title should have read "Non- Injectable Insulins Win Approval: Pfizer in the US, Generex in South America"