Oral Insulin Conditionally Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Oral-lyn, an insulin spray for people with Type 1 and Type 2 diabetes, for its Treatment Investigational New Drug (IND) program. This approval will allow Generex Biotechnology Corporation, developers of Oral-lyn, to provide early access to the medicine to people with serious or life-threatening Type 1 or Type 2 diabetes who have no satisfactory alternative treatments and who are not eligible for participation in the company’s ongoing Phase III clinical trial of the drug.

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Oral-lyn, which is currently available in Ecuador, India, and, on a very limited basis, Canada, is a formulation of Regular insulin that is sprayed into the mouth using a device similar to an asthma inhaler. The insulin is absorbed through the mucous membranes lining the mouth and begins lowering blood glucose levels in 5 minutes. It peaks at 30 minutes and stops working at 2 hours. Unlike inhaled insulins (such as the now-discontinued Exubera), Oral-lyn does not enter the lungs, both because of the design of the device used to take it, and because users are instructed not to inhale as they spray.

Generex will be providing information about the drug’s availability on the Clinical Trials Web site. This information will include details about participating sites involved in the Oral-lyn study and doctors authorized to distribute Oral-lyn through the Treatment IND program.

For more information about Oral-lyn, see the press release from Generex.

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