FDA sets PDUFA date for Zogenix' Sumavel

Zogenix, a private US specialty pharmaceutical company, says that the Food and Drug Administration has provided a target date of July 15 for  completion of its review of the New Drug Application for Sumavel DosePro  (sumatriptan injection) needle-free delivery system. Zogenix is seeking  to market the product 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 agency, which has  accepted this as a complete response, providing the new Prescription  Drug User Fee Act review date of July 15.

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 15 years, but  without many of the issues associated with needle delivery. The product  has the potential of offering migraine relief beginning in as little as  10 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.