Fast-Acting Migraine Treatment Highlighted During National Migraine Awareness Month
SUMAVEL® DosePro® Provides Treatment Option for Migraine Patients; Addresses 50% of Oral Triptan Users who are Dissatisfied with their Current Migraine Therapy
SAN DIEGO, June 6, 2011 /PRNewswire via COMTEX/ -- Thirty-six million Americans suffer from migraines, leading to more than $20 billion in medical expenses and costs related to lost productivity each year(1). In recognition of National Migraine Awareness Month and the significant unmet medical needs of migraine patients, Zogenix, Inc. (NASDAQ: ZGNX) is highlighting the importance of selecting the appropriate medication for a patient's "treatment toolbox" to address specific types of migraine episodes.
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This multi-therapy treatment strategy is endorsed by headache specialists and is supported by the results of a Phase 4 clinical study of the Company's fast-acting needle-free subcutaneous migraine treatment, SUMAVEL DosePro, which were presented at the annual meeting of the American Headache Society in Washington, D.C. The study demonstrated increased patient satisfaction, confidence and preference for SUMAVEL DosePro in the treatment of migraine attacks.
Roger K. Cady, MD, associate executive chairman of the National Headache Foundation board of directors and founder of the Headache Care Center in Springfield, MO, said, "Migraines are a serious medical condition that can severely impair a patient's ability to function in day-to-day activities. They are difficult to treat because there is a broad spectrum of migraines with significant variability in intensity, nausea, associated vomiting and speed of onset. Clinical experience suggests that the key to winning the battle is a multi-therapy approach that includes a fast-acting, convenient and easy-to use option for the more aggressive migraine attacks."
Oral triptans are a commonly prescribed class of migraine medications, however, more than 50% of migraine sufferers using oral medications have indicated they are dissatisfied with their current migraine therapy(2).
Dr. Cady continued, "The Phase 4 study results confirm that SUMAVEL DosePro can be an important component of a migraine patient's therapeutic toolbox. I believe it is important for physicians to provide their patients with treatment options to help manage the variety of attacks that patients experience."
In a Phase 4 open-label, multicenter U.S. study more than 200 adult patients diagnosed with migraine and taking triptan therapy were enrolled to evaluate overall satisfaction, confidence and preference for SUMAVEL DosePro, as well as efficacy and safety, in treating multiple migraine attacks. Key results from the study include:
- Patients reported greater overall satisfaction after treating multiple migraine attacks with SUMAVEL DosePro compared to their current triptan therapy, which was predominantly oral triptans
- Freedom from pain was achieved in 61% of migraine episodes within 2 hours
- In 33% of migraine episodes, pain relief was achieved in 15 minutes; in 70% of episodes it was achieved in 30 minutes; and in 85% and 86% of episodes it was achieved in 1 and 2 hours
- A subset of patients (90) identified as needing a change in their migraine therapy based on their Migraine Assessment of Current Therapy (Migraine-ACT) score showed dramatic improvements in treatment satisfaction after using SUMAVEL DosePro
- Patients showed a clinically relevant improvement in overall treatment satisfaction (from 17% at baseline to 62%) and confidence (from 22% at baseline to 58%) by the end of the treatment period
- Provided effective relief from migraine pain and associated symptoms
- Efficacy, satisfaction and confidence remained consistent during use for multiple migraine attacks
By including SUMAVEL DosePro as a treatment option, which currently represents less than 5% of the triptan prescriptions, these patients can access:
- Migraine pain relief beginning within 10 minutes for some patients*
- First-of-its-kind needle-free delivery system providing injectable sumatriptan option when oral therapies may be an impractical treatment option (i.e. migraine with vomiting or nausea)
- An alternative for patients with rapid onset migraines because subcutaneous sumatriptan delivery is quickly absorbed
Roger Hawley, Chief Executive Officer of Zogenix, concluded, "Our mission at Zogenix is simple and clear. We are passionately striving to make a difference for patients with moderate to severe migraine attacks through education and by offering a unique way to treat migraines. We believe that SUMAVEL DosePro fills a significant unmet medical need for migraine patients and has the potential to provide economic benefits for employers who are paying the high costs from ineffective treatments and the corresponding loss of productivity."
*In two well-controlled clinical trials (N=1104) with patients experiencing moderate or severe pain and one or more migraine symptoms, the efficacy of subcutaneous sumatriptan vs. placebo was evaluated. In these clinical trials, 16% of patients achieved relief within 10 minutes vs. 4% placebo; 70% of patients achieved relief at one hour vs. 22% placebo; and 82% of patients achieved relief at two hours vs. 39% placebo.
(1) American Migraine Foundation; http://www.americanmigrainefoundation.org/whatismigraine.aspx.
(2) National Migraine Treatment Survey on behalf of the National Headache Foundation, March 2010.
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 http://www.sumaveldosepro.com/.
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.
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 with its co-promotion partner, Astellas Pharma US, Inc., 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 http://www.zogenix.com/.
SUMAVEL(R) and DosePro(R) are registered trademarks of Zogenix, Inc.
Forward Looking Statements
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," "designed" 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 the attributes of SUMAVEL DosePro , its usefulness as a therapeutic option in relieving migraine pain and symptoms and its potential to provide economic benefits for employers. 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: the market potential for migraine treatments, and Zogenix's ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to SUMAVEL DosePro that could delay or prevent commercialization, or that could result in recalls or product liability claims; Zogenix's dependence on its collaboration with Astellas Pharma US, Inc. to promote SUMAVEL DosePro; 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 news 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.
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SOURCE Zogenix, Inc.