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Zogenix Announces sumatriptan DosePro™ NDA
Accepted for Filing by FDA
March 19, 2008
SAN DIEGO, Calif. - (March 19, 2008): Zogenix, Inc. ("Zogenix"),
a private, specialty pharmaceutical company, today announced that
its New Drug Application (NDA) for sumatriptan DosePro™ has
been accepted for filing by the U.S. Food and Drug Administration
(FDA). Zogenix is seeking marketing approval from the FDA of sumatriptan
DosePro for the acute treatment of migraine attacks with or without
aura and cluster headache episodes. The FDA will take action on
its application in late 2008.
Sumatriptan DosePro (formerly known as Intraject® sumatriptan)
utilizes Zogenix's proprietary DosePro needle-free drug delivery
system to subcutaneously administer sumatriptan for the treatment
of migraine and cluster headache. Sumatriptan DosePro is a fast
acting therapy that patients can self-administer in three easy
steps. Based on Zogenix's clinical bioequivalence studies, the
company has concluded that sumatriptan DosePro is bioequivalent
to injectable sumatriptan (IMITREX STATdose System®) when administered
in the thigh or abdomen. Given the unique attributes of sumatriptan
DosePro, Zogenix believes it has the potential to be used as a
replacement for needle-based injectable forms of sumatriptan, as
well as oral and nasal spray triptans.
"We are very pleased to have our first NDA accepted for filing
by the FDA," said Roger L. Hawley, Chief Executive Officer. "In
just eighteen months, we have progressed from a start-up stage
company to one now with our first product under review by the FDA
for approval."
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. For additional information, visit www.zogenix.com.
Zogenix™, DosePro™ and INTRAJECT® are trademarks
of Zogenix, Inc. Imitrex STATdose System® is a registered trademark
of GlaxoSmithKline

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