Zogenix Obtains Approval In U.S. For Sumavel™ DosePro™

Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Jul 2009 - 6:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Aradigm Corporation (OTC BB: ARDM.OB) ("Aradigm") announced that Zogenix, Inc. was granted approval of the Sumavel™ DosePro™ (sumatriptan injection) needle-free delivery system which enables subcutaneous delivery of sumatriptan without a needle for the treatment of acute migraine. Aradigm is entitled to a $4 million milestone payment upon first commercial sale, and royalty payments upon any sales of products in the U.S. and other countries, including the European Union, which may be developed and sold using the DosePro technology.

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.

In August 2006, Aradigm sold all of its assets related to the Intraject™ needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix, Inc., a private company. Zogenix is responsible for development and commercialization efforts of Intraject (now rebranded under the name DosePro).

Source
Aradigm