Zogenix Announces sumatriptan DosePro™ NDA Accepted for Filing by FDA
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.”
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
Imitrex STATdose System® is a registered trademark of GlaxoSmithKline
VP, Commercial Strategy & Corporate Communications