SAN DIEGO and DEERFIELD, Ill., Jan. 13 /PRNewswire/ -- Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, and Astellas Pharma U.S., Inc. (“Astellas”) announced today the U.S. commercial launch of SUMAVEL(TM) DosePro(TM) (sumatriptan injection) needle-free delivery system. In July 2009, the U.S. Food and Drug Administration approved SUMAVEL DosePro for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headaches. SUMAVEL DosePro delivers subcutaneous sumatriptan, a treatment that provides migraine relief starting within 10 minutes for some patients*, in a first-of-its-kind needle-free delivery system. SUMAVEL DosePro is expected to be available at most retail pharmacy outlets this month.
SUMAVEL DosePro offers other practical benefits. Approximately 30 percent of patients report vomiting as a symptom of migraine attacks, and the vast majority of attacks are also accompanied by nausea(1). During these episodes, oral therapies may be an impractical treatment option. Further, while most forms of triptans can be effective when taken early in a migraine attack, patients who experience rapid onset of migraines, or those that occur upon waking may not always achieve the fast relief they would like from tablet and nasal forms. Quickly absorbed subcutaneous sumatriptan may offer an alternative for these patients, although until now, it was only available in a needle-based system. New SUMAVEL DosePro delivers sumatriptan subcutaneously (under the skin) without a needle, which can offer fast relief in a patient-friendly delivery system.
Zogenix and Astellas have an exclusive co-promotion agreement to market SUMAVEL DosePro needle-free delivery system in the United States. Zogenix is focusing its sales activities primarily on the neurology market while Astellas is focusing principally on primary care physicians.
About SUMAVEL DosePro
SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.
About DosePro Technology
The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than 10 years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.
About Astellas
Astellas Pharma U.S., Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of anti-infectives, cardiovascular, dermatology, immunology, neuroscience, and urology. For more information about Astellas Pharma U.S., Inc., please visit www.us.astellas.com.
(1) Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001
CONTACT: Investors, David Nassif of of Zogenix, Inc., +1-858-436-8583,
ir@zogenix.com, or Media, Catherine O’Connor of Zogenix, Inc.,
+1-858-436-3374, coconnor@zogenix.com, or Jenny Keeney of Astellas US LLC,
+1-847-317-5405, jenny.keeney@us.astellas.com, or Jackie Quintanilla of
Edelman, +1-323-202-1053, jacqueline.quintanilla@edelman.com
Web site: http://www.zogenix.com/
http://www.us.astellas.com/
