June 30, 2008
Zogenix Reports Positive Results From Sumatriptan DosePro Study
Zogenix has announced successful results from two clinical studies of sumatriptan DosePro, a product in development for treatment of acute migraine and cluster headache.
The first clinical study evaluated the pharmacokinetics, bioequivalence and safety of needle-free sumatriptan DosePro, compared to a needle-based autoinjector, Imitrex STATdose used in the treatment of migraine. DosePro is a novel, patented, needle-free technology that 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 showed that maximum plasma concentrations of sumatriptan were reached rapidly, within approximately 12 minutes. Sumatriptan DosePro and Imitrex STATdose treatments also exhibited highly similar safety profiles.
The second study, in which patients at home used sumatriptan DosePro as their primary means of treating migraine headache, demonstrated that 98% of patients were able to correctly use the simple three-step DosePro technology on their first try, even in the midst of an acute migraine attack.
Stephen Farr, president and COO of Zogenix, said: "This unique combination of ease of use and rapid sumatriptan absorption could provide a new option for migraine patients who are currently not satisfied with their existing therapy which can take hours to reach peak absorption or require cumbersome needle-based delivery. If approved by the FDA, we are preparing for a launch of this product in early 2009."