SAN DIEGO, Feb. 18 /PRNewswire/ -- 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.
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|SOURCE Zogenix, Inc.|
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