SAN DIEGO, June 25, 2013 (GLOBE NEWSWIRE) -- In conjunction with National Migraine Awareness Month and in recognition of the significant unmet needs of migraine sufferers, Zogenix, Inc. (Nasdaq:ZGNX) is launching a new and improved SUMAVEL® DosePro® Migraine Toolbox to support patient education and empowerment. The Migraine Toolbox highlights the importance of having the appropriate medication on hand in the patient's "treatment toolbox" to address the specific migraine attack the patient is experiencing.
Dr. Stephen Silberstein, Professor and Director of the Jefferson Headache Center at Thomas Jefferson University, Philadelphia, Pennsylvania, said, "The frequency, intensity and speed of onset of migraines can vary greatly for patients so it is vital that migraine sufferers follow U.S. Headache Consortium Migraine treatment guidelines which recommend having access to a toolbox of treatment options. This includes medication such as oral and injectable triptan therapies that are fast-acting, convenient and easy-to use for more aggressive migraine attacks. In addition, education regarding treatment options is a key component of every migraine patient's treatment plan."
The Migraine Toolbox reinforces the role of SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) in treating specific types of migraine attacks such as those that cause patients to wake up or throw up, or require a fast-acting backup plan when migraines come on suddenly or recur. A National Headache Foundation survey of 500 migraine sufferers found that the majority of sufferers (54 percent) said their prescription oral migraine medication is not useful for every migraine attack, yet less than 20 percent of such sufferers use backup prescribed medication when an oral tablet is not an option.1
Roger L. Hawley, chief executive officer of Zogenix, said, "Migraine is more than a headache. The Migraine Toolbox has become a standard part of migraine care in physician offices across the country where they are using the national migraine treatment guidelines to enhance outcomes. The patient focus is on attack-based care which empowers the patient to select the appropriate form of triptan treatment based on the severity, symptoms and circumstances of that specific attack. While oral triptans can often be the right choice, many patients have specific attacks where they know their oral medication may not give the pain-free outcome they need to be functional. The Toolbox has become an excellent education resource for migraine suffers and for these physicians who follow the treatment guidelines. Our goal is to keep making the Migraine Toolbox better based on customer feedback."
The updated Migraine Toolbox, which is provided to patients by their physician, is more compact for easy storage and patient use. It contains several enhancements and important patient education materials, including:
In a survey of more than 1,500 people using SUMAVEL DosePro, 3 out of 4 patients would recommend other migraine sufferers talk to their doctor about SUMAVEL DosePro.2 Migraine pain relief can start within 10 minutes with SUMAVEL DosePro (16 percent of patients vs. 4 percent for placebo), with studies demonstrating that 82% of patients achieved pain relief at 2 hours (vs. 35 percent with placebo) and 64 percent of patients were pain free within 2 hours (vs. 15 percent with placebo)3.
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.
INDICATION and IMPORTANT LIMITATIONS
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 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. SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. 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, go to http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit http://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, 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. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER. Zogenix's second investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia; an investigational new drug application was submitted to the FDA in May 2012.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding SUMAVEL DosePro's usefulness as a therapeutic option in relieving migraine pain and symptoms. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: unexpected adverse side effects relating to Sumavel DosePro that could result in recalls or product liability claims; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM ER are trademarks of Zogenix, Inc.
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