Zogenix Reports FDA Provides New PDUFA Date for Sumavel™ DosePro™
- Potential Final Approval July 2009 -
SAN DIEGO, Calif. – (February 18, 2009): Zogenix, Inc. (“Zogenix”), a private, specialty pharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has provided a target date of July 15, 2009 for completion of its review of the NDA for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Zogenix is seeking marketing approval of Sumavel DosePro for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes.
In October, the company received a Complete Response letter from the FDA citing the need for a single additional in vitro test to be conducted. Zogenix recently submitted this information to the FDA. The FDA has accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.
Sumavel DosePro uses the novel, proprietary DosePro drug delivery system to subcutaneously administer sumatriptan, a medication that has been used to treat migraines effectively and safely for over fifteen years, but without many of the issues associated with needle delivery. Sumavel DosePro has the potential of offering migraine relief beginning in as little as ten minutes, in a system sufferers can self administer in three easy steps. Given the unique attributes of Sumavel DosePro, Zogenix believes it has the potential to be used as a replacement for needle-based injectable forms of sumatriptan, as well as to replace tablet and nasal spray triptans for challenging migraine episodes.
Migraine affects approximately 30 million people in the United States. Patients suffer with extreme pain, nausea, vomiting, and sensitivity to light and sound, making it difficult to undertake work or other activities. Because of this, speed of relief is a key attribute identified by migraine patients when choosing a medication.
“We look forward to working with the FDA to help make this important alternative treatment available to patients who suffer from migraines,” said Roger L. Hawley, Chief Executive Officer of Zogenix. “We are building commercial inventory and our launch plans are in place. It is our intention to launch the product following FDA approval in the second half of 2009.”
Zogenix, Inc., with offices in Emeryville and San Diego, Calif, 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, Sumavel DosePro, 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 Sumavel DosePro in December 2007. The company also plans to license the patented DosePro needle-free drug delivery system to other companies. The company’s second product candidate, ZX002, is a novel, oral controlled release formulation of hydrocodone for the treatment of chronic pain. This product candidate has completed Phase 2 clinical trials and is ready to begin Phase 3. For additional information, visit www.zogenix.com.
Zogenix™, Sumavel™, and DosePro™ are trademarks of Zogenix, Inc.