Zogenix Announces Publication of SUMAVEL(R) DosePro(R) Phase 4 Clinical Data
SAN DIEGO, Aug 4, 2011 (GlobeNewswire via COMTEX) --
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today the publication of its SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery system Phase 4 clinical study results. The study, which demonstrated increased patient overall satisfaction, confidence and preference for SUMAVEL DosePro amongst current triptan users in the treatment of multiple migraine attacks, will be published in the September issue of the peer-reviewed journal Headache, The Journal of Head and Face Pain. Headache is the official publication of the American Headache Society (AHS).
The publication, which is titled "Satisfaction With and Confidence in Needle-Free Subcutaneous Sumatriptan in Patients Currently Treated with Triptans," is currently available online on the journal's website.
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 lead author of the study, said, "The Phase 4 study results support the use of SUMAVEL DosePro as an important treatment option for migraine patients, such as those with aggressive, rapid-onset attacks. It provides a fast-acting and easy-to-use injectable triptan therapy option for patients to use as part of their migraine toolbox in conjunction with their oral triptan medications so that the right medication can be used for specific attacks."
Please click here to view additional commentary by Dr. Cady regarding migraine treatment and the SUMAVEL DosePro Phase 4 clinical data, which was highlighted during National Headache Month at the 2011 annual meeting of the AHS in Washington, D.C.
About the Phase 4 Clinical Study
Zogenix completed the Phase 4 open-label, multicenter study in the United States to evaluate treatment overall satisfaction, treatment confidence, patient preference, and treatment tolerability for SUMAVEL DosePro in adult patients diagnosed with migraine and currently treated with triptans. More than 200 patients, who were predominantly taking oral triptan therapy, tried SUMAVEL DosePro to treat at least one and up to four migraines over a 60-day period, with the primary endpoint being the change in overall satisfaction. The study utilized the Patient Perception of Migraine Questionnaire-Revised, or PPMQ-R, a validated instrument, to evaluate patient satisfaction with migraine treatment through analysis of efficacy, functionality, ease of use and tolerability/side effects.
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-HT1 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.
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(R) DosePro(R) (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead product candidate, Zohydro(TM) (hydrocodone bitartrate), is a novel, oral, single-entity extended-release capsule formulation currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second DosePro product candidate, Relday(TM), is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia and bipolar I disorder. Zogenix expects to begin clinical studies of Relday in early 2012.
For additional information, please visit www.zogenix.com.
SUMAVEL (R), DosePro (R), Relday(TM) and Zohydro(TM) are trademarks of Zogenix, Inc.
Cady, R. K., Aurora, S. K., Brandes, J. L., Rothrock, J. F., Myers, J. A., Fox, A. W. and Farr, S. J. (2011), Satisfaction With and Confidence in Needle-Free Subcutaneous Sumatriptan in Patients Currently Treated with Triptans. Headache: The Journal of Head and Face Pain. doi: 10.1111/j.1526-4610.2011.01972.x
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