First in Bananas and Noninjectable Insulin

Ecuador Approves Insulin Spray

| Jul 1, 2005

Generex Biotechnology announced that its noninjectable insulin formulation is now available—in Ecuador at least.

Ecuador is the first country where a noninjectable version of insulin has ever been available. According to the International Diabetes Federation, there are approximately 360,700 people with diabetes in Ecuador.

In a May 3, 2005, press release, Generex Biotech said, “Generex believes that this approval will pave the way for additional jurisdictional approvals around the world.”

Generex says it intends to start phase III trials of Oral-lyn in Canada and Europe later this year.

Source: Generex Biotechnology

Gerald Bernstein, MD, FACP, is the vice president of medical affairs at Generex Biotechnology.

How are the efforts going to get Oral-lyn approved in the United States, and what are the obstacles?

I don’t see any real obstacles other than the natural processes of the FDA. Although studies have been done and will continue to be done in the United States, the formalities of moving to phase 3 here is a strategic one. The FDA has a file of Generex activities, which we keep current.

How is insulin spray different from inhaled insulin?

Most important is not to confuse buccal delivery (via the mouth) with pulmonary delivery (via the lungs). The former is visible and safe. The latter is invisible and could be risky.

How is the dynamic of insulin spray different from that of injectable insulin?

When you inject insulin, it is deposited into the skin. It sits there and migrates to blood vessels. This gives four- to six- or six- to eight-hour PK curves. When you spray, it either crosses the buccal mucosa and rapidly enters the blood stream, or it is swallowed and destroyed. Thus, no tail. The duration of activity is about two hours with no tail, reducing risk for hypoglycemia.

What are some practical tips for people switching from injectable to spray insulin?

As with all new products, dose adjustment is approximated and then fine-tuned by experience.

Other Noninjectable Insulin in Hands of FDA

Pfizer, Inc., and the Sanofi-Aventis Group announced that the United States Food and Drug Administration (FDA) has accepted for filing a new drug application for the inhaled insulin Exubera.

Exubera is inhaled into the lungs prior to eating. Pfizer and Sanofi-Aventis are seeking approval to market Exubera for adult patients with type 1 and type 2.

Exubera is currently also under review by the European Medicines Evaluation Agency.

Source: Pfizer, Inc.
March 2, 2005

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