The results of a new study conducted with healthy volunteers show that an investigational oral insulin spray formulation “is mainly absorbed and effective in the first 2 hours after its administration, which is the crucial time period” for control of blood sugar after a meal. The possibility of using “insulin just a few minutes before meals represents a substantial improvement in quality of life,” researchers said on Wednesday.

With the ORA-LYN insulin spray, said Dr. Gerald Bernstein from Generex Biotechnology, Toronto, “human regular insulin (used for many years) is delivered with an asthma-like device (common and familiar to patients and doctors)... by a metered spray.”

Dr. Simona Cernea and colleagues from Hadassah Hebrew University Hospital, Jerusalem, Israel compared the new formulation with injectable regular insulin in seven healthy volunteers.

Except for the highest dose of oral insulin spray (20 puffs), maximum insulin concentrations were significantly lower for the spray than for injected insulin, the authors report in the journal Diabetes Care, but there was a clear dose-response in blood concentrations of insulin with the spray.

Total insulin delivered was substantially lower with the insulin spray than with injected insulin, the report indicates. The time to maximum insulin concentration, however, was significantly shorter for oral insulin spray than for injected insulin, the researchers note.

“Increasing doses of oral insulin resulted in a dose-dependent increase in (blood) insulin concentrations and subsequent (sugar)-lowering effects,” the researchers report.

Berstein hopes the simplicity of an oral insulin spray “will facilitate acceptance and increase use by primary care physicians and patients alike. Patients with Type 1 Diabetes will be willing to administer insulin more often and patients with Type 2 diabetes will be willing to utilize insulin earlier in treatment rather than as a last resort.”

He added, “The product has been licensed in Ecuador and we hope to have it available for consumption some time this summer… Following a successful launch, we will seek to market ORA-LYN in additional South American countries.”

SOURCE: Diabetes Care, June 2005.