Needle-Free Migraine Drug Formulation Clears Clinical Trials
Results from two clinical trials show that Zogenix’s needle-free DosePro formulation of the migraine drug sumatriptan reaches peak levels in patients’ blood in minutes.
The trial results, which were presented at the 50th annual meeting of the American Headache Society in Boston, will be used to support its NDA for DosePro.
The first of two studies evaluated DosePro’s pharmacokinetics, bioequivalence and safety compared with a needle-based autoinjector, GlaxoSmithKline’s Imitrex STATdose. DosePro delivers the drug directly through the skin into the subcutaneous space without a needle.
In the study involving healthy adult subjects, sumatriptan DosePro was bioequivalent to the needle-based autoinjector in the abdomen and thigh injection sites, and maximum plasma concentrations of sumatriptan were reached in approximately 12 minutes. The two treatments had similar safety profiles.
A quick peak of plasma concentration is important for migraine drugs because it correlates with speed and completeness of response to migraine symptoms, Zogenix said.
In the second study, patients at home used the product as their primary means of treating migraine headache, and 98 percent were able to correctly use the technology on their first try, even while undergoing an acute migraine attack.