SAN DIEGO, Sept. 27, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today the availability of new migraine patient resources accessible at www.SUMAVELDosePro.com in support of National Pain Awareness Month. One in every four households in the U.S. has a migraine sufferer, which impacts productivity in the workplace, in school and in managing household work. The new resources offer people affected by migraines, as well as caregivers, family and friends, an opportunity to learn more about the condition, view video testimonials from people who suffer from migraines and physicians who specialize in the treatment of headaches, and educate themselves on the U.S. Headache Consortium Migraine Treatment Guidelines provided by the American Headache Society and the American Academy of Neurology. Migraine attacks can strike at any time and at any speed, and the severity of symptoms can vary from one attack to the next for the same individual. Consequently, the U.S. Headache Consortium Migraine Treatment Guidelines recommend matching the intensity of care with the level of severity and symptoms of the attack. Using a toolbox approach to migraine management allows the migraine sufferer to have the appropriate medication on hand for the specific attack they are experiencing. Roger K. Cady, MD, associate executive chairman of the National Headache Foundation board of directors, founder of the Headache Care Center in Springfield, MO, and featured testimonial, said, "The goal of migraine treatment is complete relief of pain and symptoms, so you can quickly return to normal functioning. Providing educational resources to help migraine patients talk to their physicians, learn how to manage their condition and use their medication correctly is an important component to migraine treatment." Dr. Cady added, "In my practice, I recommend a toolbox approach to managing migraines. Oral medications are often sufficient for mild or slower onset migraines. However, other treatment options are often needed for patients that wake up with a migraine, experience nausea and vomiting with their migraine, or as a back-up option when migraines come on suddenly or recur."
"Zogenix is committed to raising awareness of migraine as a debilitating condition and encouraging dialogue between patients and physicians, especially for those with a diminished quality of life," said Roger Hawley, chief executive officer of Zogenix. "SUMAVELDosePro.com provides a unique combination of online educational resources and real-life experience that is relevant for patients and their families. We hope that they will benefit from these new online resources as they seek information about managing migraine."Among other features, the website also includes a doctor discussion guide, migraine survey, pharmacy postcard, migraine diary and how to videos on SUMAVEL ® DosePro ®. For more information, visit www.SUMAVELDosePro.com. 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. SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose. 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.
Do not use Sumavel DosePro and any ergotamine-containing or ergot-type medication within 24 hours of each other; do not use SUMAVEL DosePro and another 5-HT 1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour). SUMAVEL DosePro is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.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. For full prescribing information, please click here: http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com. About Zogenix Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL ® DosePro ® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ ER (hydrocodone bitartrate) is an oral, extended-release formulation of various strengths of hydrocodone, without acetaminophen, intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER and an Investigational New Drug Application for Relday. The FDA assigned a PDUFA target action date of March 1, 2013, for the Zohydro ER NDA. For additional information, please visit www.zogenix.com. SUMAVEL ®, DosePro ®, Relday TM and Zohydro TM are trademarks of Zogenix, Inc.
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