The FDA has approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program.
The spray delivers prandial insulin orally through a device similar to an asthma inhaler, which sprays it on the inside of the cheek, rather than via injection.
Researchers have spent much time looking for alternative means of dispensing insulin to diabetics, and the IND program allows patients with serious or life-threatening conditions, and without suitable alternative treatment, to access drugs otherwise available only to those in a clinical trial.
For a drug to receive IND approval, it must demonstrate efficacy during clinical trials.
"We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment," said Anna Gluskin, president and chief executive officer of drug manufacturer Generex, in a prepared statement.
Generex is a subsidiary of Antigen Express.