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.
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."