Zogenix to Present Additional SUMAVEL(R) DosePro(R) Phase 4 Results at Headache Meetings in June
New Data Analyzes Efficacy, Tolerability, and Patient Preference for SUMAVEL DosePro Among Current Triptan Users Requiring a Change in Migraine Therapy
SAN DIEGO, May 27, 2011 (GlobeNewswire via COMTEX) -- Zogenix, Inc. (Nasdaq:ZGNX) today announced that additional data from the Company's Phase 4 clinical study of SUMAVEL(R) DosePro(R) (sumatriptan injection) Needle-free Delivery System will be presented at two upcoming scientific meetings: the American Headache Society(R) 53rd Annual Scientific Meeting (AHS), to be held June 2 -- 5, 2011 in Washington, DC; and the 15th Congress of the International Headache Society (IHS), to be held June 23 -- 26, 2011 in Berlin, Germany.
The Phase 4 open-label, multicenter U.S. study evaluated overall satisfaction, confidence and preference for SUMAVEL DosePro in treating multiple migraine attacks in more than 200 adult patients diagnosed with migraine and currently taking triptan therapy. Efficacy, including onset and sustained duration of pain relief/freedom from pain, and tolerability of therapy with SUMAVEL DosePro were also measured. Data will also be reported from a subset of 90 patients identified by a clinical assessment of current migraine therapy as requiring a change in therapy.
Posters to be presented at these meetings include the following:
Title: Current Triptan Users Requiring a Change in Migraine Therapy Demonstrated Improved Treatment Satisfaction and Confidence After Trying SUMAVEL(R) DosePro(R) for up to 4 Migraine Attacks Rothrock J, Cady R, Aurora SK, Brandes JL, Myers JA, Fox Authors: AW, Farr SJ Poster No: P14 (AHS); 166 (IHS) Title: Improved Treatment Satisfaction and Confidence Among Current Triptan Users Trying SUMAVEL(R) DosePro(R) (needle-free subcutaneous sumatriptan) for Up to 4 Migraine Attacks Cady R, Aurora SK, Brandes JL, Rothrock J, Myers JA, Fox Authors: AW, Farr SJ Poster No: P21 (AHS); 165 (IHS) Title: Multiple-Attack Efficacy and Tolerability of SUMAVEL(R) DosePro(R) (needle-free subcutaneous sumatriptan) Among Current Triptan Users Brandes JL, Rothrock J, Cady R, Aurora SK, Myers JA, Fox Authors: AW, Farr SJ Poster No: P6 (AHS); 167 (IHS)
The posters will be displayed in the Constitution Ballroom at the Grand Hyatt Hotel in Washington DC during AHS Thursday, June 2, 2011, through Sunday, June 5, 2011. They will be on display in the Exhibition Area at the Maritim Hotel Berlin Thursday, June 23, 2011 during IHS.
Zogenix and its co-promotion partner, Astellas Pharma US, Inc., launched SUMAVEL DosePro in the United States in January 2010 for the acute treatment of migraine and cluster headache.
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.
SUMAVEL DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and 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, go to http://www.zogenix.com/docs/SV0018.0709A_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 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, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.
For additional information, please visit www.zogenix.com.
SUMAVEL(R) and DosePro(R) are registered trademarks of Zogenix, Inc.
This news release was distributed by GlobeNewswire, www.globenewswire.com
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