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.
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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
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
currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.
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Zogenix(TM) and DosePro(TM) are trademarks of Zogenix, Inc.
SUMAVEL(R) is a registered trademark 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 commercial potential of the product, the potential to broaden the application of the DosePro technology, the timing of Desitin's planned launch in Germany, and the potential for MAA submissions and commercialization of SUMAVEL DosePro in other E.U. markets. 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 ability to identify and acquire or in-license additional drug compounds that can be delivered via the current version of the DosePro technology, to out-license the technology to third parties and/or its ability to successfully develop and receive requisite approvals for higher dose versions of the technology; the ability of Zogenix and Desitin to ensure adequate and continued supply of SUMAVEL DosePro to successfully launch commercial sales or meet anticipated market demand in the E.U.; the scope, validity and duration of patent protection and other intellectual property rights for SUMAVEL DosePro; whether the approved label for SUMAVEL DosePro is sufficiently consistent with such patent protection to provide exclusivity for SUMAVEL DosePro; Zogenix's and Desitin's ability to operate their businesses without infringing the intellectual property rights of others; Zogenix's reliance on Desitin for the commercial sales success and regulatory approval and compliance of SUMAVEL DosePro in the E.U.; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.