Zogenix Announces Clinical Study Results For Sumatriptan DosePro™, A Novel Migraine Treatment

Main Category: Headache / Migraine
Also Included In: Pain / Anesthetics
Article Date: 30 Jun 2008 - 4:00 PDT

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Zogenix, Inc. ("Zogenix"), a private, specialty pharmaceutical company, announced that it will present successful results from two clinical studies of sumatriptan DosePro, a product in development for treatment of acute migraine and cluster headache, at the 50th Annual American Headache Society Meeting in Boston, Massachusetts.

The first clinical study evaluates 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. An early time to peak plasma concentration for migraine drugs is important because it has been shown to correlate with speed and completeness of the response to symptoms of migraine headache. 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.

"Sumatriptan DosePro provides the most widely prescribed migraine medication in the U.S., sumatriptan, in a novel needle-free delivery system that allows the drug to reach peak blood levels in approximately twelve minutes and takes only three simple steps to deliver," said Stephen Farr, Ph.D., President and Chief Operating Officer of Zogenix. "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 FDA, we are preparing for a launch of this product in early 2009."

Details of the poster presentations are as follows:

Usability of the Sumatriptan DosePro™ Needle-Free System in Adult Migraineurs during Acute Migraine Attack outside of the Clinic; S.J. Farr, L.S. Linn, P. Shabe, E. Newman, & P. Chandler; Poster ID S2; June 28, 12:15-1:30pm EDT.

Pharmacokinetics, Bioequivalence, and Safety of the Sumatriptan DosePro™ Needle-Free System vs. IMITREX STATdose® in Healthy Adults; J.L. Brandes, R.K. Cady, T.R. Smith, F.G. Freitag, L.S. Linn, & S. J. Farr; Poster ID S7; June 28, 12:15-1:30pm EDT.

About Zogenix

Zogenix, Inc., with offices in Emeryville and San Diego, CA, is a private, specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system disorders and pain. The company's lead product candidate, sumatriptan DosePro (previously Intraject®), enables needle-free subcutaneous delivery of sumatriptan for the treatment of acute migraine and cluster headache. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for sumatriptan DosePro in December 2007, and it was accepted for filing by the FDA in March 2008. Zogenix's second product candidate, ZX002, is a novel controlled release formulation of hydrocodone for the treatment of chronic pain. This product candidate has completed Phase 2 clinical trials, and the company anticipates initiating the Phase 3 clinical program in the second half of 2008. The company also plans to license the patented DosePro drug delivery system to other companies.

http://www.zogenix.com

Zogenix™, DosePro™ and INTRAJECT® are trademarks of Zogenix, Inc.

IMITREX STATdose® is a registered trademark of GlaxoSmithKline.

http://www.zogenix.com