Shreya Life Sciences, Generex Biotechnology's licensee in India, has provided an update on the status of the clinical and regulatory programme for Oral-lyn, Generex' buccal insulin spray product in the country, where the product is branded as Recosulin.
At present, Shreya is undertaking a Phase III study of Oral-lyn as part of the process of assuming commercial distribution of the product in India. To date, 125 patients have completed the study at 14 sites in India. The company has advised that trials at all sites will be completed by the end of July 2012, at which point statistical data analysis of the more than 200 patients will be undertaken. Shreya has indicated that, before the end of August, 2012, it expects to submit completed study data to the Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. The company hopes to secure final marketing approval from the Indian government before the end of this year.
Oral-lyn is an oral insulin formulation that is delivered directly into the mouth via Generex' RapidMist device, where it is absorbed into the bloodstream through the buccal mucosa. It is designed to be used for the treatment of both Type I and II diabetes. Diabetics can continue to self-administer the insulin doses they need to manage their blood glucose levels, but without needles.