The randomized single-dose study was designed to evaluate the pharmacokinetics of sumatriptan, a drug used to treat migraines, at three injection sites in 24 healthy adult male and female volunteers who had never self-injected with Intraject. They were asked to dose themselves in the thigh, abdomen and arm.
According to the company, the study demonstrated that healthy naive users could successfully administer the drug via Aradigm’s needle-free Intraject system.
The results also indicated that Aradigm’s new treatment is able to achieve bioequivalent blood plasma levels to the currently marketed subcutaneous needle-injected product.
“We believe the simplicity of the system will be very important for migraine patients who are frequently cognitively-impaired during their migraine attacks and as a result find injections very difficult to do,” said Bryan Lawlis, Aradigm’s president, “This, together with the needle-free advantage, is likely to favorably position this product for the treatment of migraine headache.”