Zogenix Announces SUMAVEL(R) DosePro(R) Named Patient Program
SAN DIEGO, Apr 12, 2011 (GlobeNewswire via COMTEX) -- Zogenix, Inc. (Nasdaq:ZGNX) today announced the establishment of a Named Patient Program for SUMAVEL(R) DosePro(R) (sumatriptan injection) Needle-free Delivery System. A Named Patient Program is a mechanism through which physicians can legally and ethically prescribe drugs which are investigational or not yet approved in a specific country.
SUMAVEL DosePro is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. SUMAVEL DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan as a potential treatment alternative to oral and nasal triptan formulations, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. These unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraines and migraines with vomiting.
Zogenix and its co-promotion partner, Astellas Pharma US, Inc., launched SUMAVEL DosePro in the United States in January 2010. The Company's development and commercialization partner in Europe, Desitin Arzneimittel GmbH, has secured several marketing authorizations in Europe and has launched SUMAVEL DosePro in Germany.
Clinigen Pharma Limited, a UK-based global provider of specialist and unlicensed medicines, will manage the Named Patient Program and supply SUMAVEL DosePro to healthcare providers in countries where SUMAVEL DosePro is not yet registered.
Roger L. Hawley, Chief Executive Officer of Zogenix, stated, "We are committed to improving patient access to SUMAVEL DosePro in a legal and ethical manner, and Clinigen is an established leader in executing named-patient programs. Our agreement provides a valuable resource for healthcare professionals and migraine patients who are unsatisfied with their current approved treatment options to access SUMAVEL DosePro on a named-patient basis."
Scott Smith, Chief Operating Officer of Clinigen Pharma said: "We are delighted to have been selected by Zogenix. The Clinigen team has extensive international experience of delivering and supporting Named Patient Supply programs and we look forward to receiving and fulfilling requests for treatment."
Contact Information for the Program Contact: Clinigen Customer Services Telephone: +44 (0) 1283 494340 Fax: +44 (0) 1283 494341 firstname.lastname@example.org E-mail: k
About SUMAVEL(R) DosePro(R)
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.
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.
Clinigen provides global access solutions for specialist medicines and Named Patient Programs. The UK-based company develops solid, flexible and effective partnerships to facilitate and address the needs of patients, healthcare professionals and biopharmaceutical companies.
For more information, visit www.clinigen.co.uk.
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 investigational 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.
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 and the potential for it to be prescribed under the Named Patient Program. 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 reliance on Clinigen to manage the Named Patient Program 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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