|On November 1, India's Central Drugs Standard Control Organization approved a regular insulin oral spray (Oral-lyn, Generex Biotechnology Corp, distributed by Shreya Life Sciences Pvt).
The product can be used as a preventative pharmacologic agent by people with prediabetes to delay disease onset and by type 2 diabetics to delay the onset of insulin dependence. It also may be used in place of subcutaneous injections in diabetic patients who require insulin.
"The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity," the company says on its Web site, adding that the product represents an ideal prandial insulin because it can be conveniently administered immediately before meals with little prospect of hypoglycemia.
Other benefits expected to improve patient compliance and thereby reduce diabetic complications include needle-free (pain-free) technology and ease of self-administration via the precise RapidMist device.
Insulin oral spray previously was approved for use in Ecuador; long-term clinical trials are ongoing in Canada and Europe to support its safety and efficacy.