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New Buccal Insulin Approved by the FDA but with Conditions

Posted: Wednesday, September 16, 2009

Generex Biotechnology Corporation, an innovator for drug delivery for metabolic diseases through the inner lining of the mouth, announced that the U.S. FDA has granted approval for the treatment use of Oral-lyn™ under the FDA’s Treatment Investigational New Drug (IND) program.

The FDA’s Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.

Under a structured Treatment IND protocol, Generex Oral-lyn ™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the company’s ongoing global Phase III pivotal clinical trial.

This Treatment IND will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.

In order to learn more about the availability of Generex Oral-lyn™ under the IND Treatment program, as per FDA requirements, the company will be providing information within the www.ClinicalTrials.gov website. Details will include study design and participating sites and/or physicians. Please note that the drug will be available only through physicians who are registered in the Treatment IND program.

"We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment and have contacted the company, based on their special needs, about possible access to Generex Oral-lyn™," stated Anna Gluskin, Generex’s President and Chief Executive Officer. "This opportunity to provide those in critical need of Generex Oral-lyn™ will continue while the pivotal Phase III study concludes and the company prepares for its New Drug Submission with the USFDA and other major health authorities in key markets."

Source: Diabetes In Control: FDA news Release