Zogenix to Present New Case Study Highlighting Successful Repositioning of Injectable Sumatriptan for Migraine With a Novel Needle-Free Delivery Technology
SAN DIEGO, Oct. 23, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that John Turanin, vice president and general manager, Zogenix technologies, is scheduled to make a presentation that highlights successful repositioning of injectable sumatriptan for migraine with a novel needle-free delivery technology at the 2nd Annual Drug Repositioning & Indications Discovery Conference, which is being held on October 23-24, 2012 in San Francisco, Calif. The case study demonstrates increased physician and patient adoption of a standard therapy when enhanced with the DosePro® Needle-free Delivery System.
Mr. Turanin's presentation, which will take place at 9:30 am PT on October 23, is a case study on Zogenix's first commercialized product utilizing DosePro technology, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, for the acute treatment of migraine and cluster headache. Mr. Turanin will examine the introduction of SUMAVEL DosePro to the U.S. market, including an analysis of the factors affecting the adoption of injectable products. For SUMAVEL DosePro, this included patient acceptance of a needle-free subcutaneous self-injection product despite the availability of oral or nasal alternatives.
"In today's marketplace, unique delivery technology can be a competitive advantage and a key driver of product adoption. In developing SUMAVEL DosePro, we successfully leveraged the unique properties of the DosePro needle-free delivery system to reposition the under-utilized standard subcutaneous treatment for migraine, sumatriptan injection, into a novel treatment option that simplifies the patient experience. As a result, we have seen increased utilization of injectable triptans," stated Mr. Turanin.
Turanin continued, "We view DosePro as an enabling delivery technology for both new and existing therapeutics that require or benefit from subcutaneous administration. It is particularly well suited for the delivery of highly viscous drug formulations such as biologics, which cannot be delivered via a traditional needle and syringe."
Zogenix has manufactured and shipped over 2,000,000 commercial DosePro units. DosePro needle-free delivery system is currently being co-marketed with Battelle, the world's largest independent research and development organization, to potential biopharmaceutical and government clients. The companies have embarked on a "Less is More" campaign that aims to showcase the simplicity and benefits of the DosePro technology and its ability to provide instantaneous, needle-free, subcutaneous drug delivery.
For more information on the DosePro needle-free delivery system, please visit www.DosePro.com.
About the 2nd Annual Drug Repositioning Conference
Presenters and panelists will share with the audience best practices, new technologies, case studies, and regulatory developments in drug repositioning and indications discovery. It will feature a variety of speakers from academia, industry, non-profits and government. Their perspectives will provide insight into the field of drug repositioning and the challenges and successes in getting a repositioned drug to the marketplace. Building on last year's conference, the 2nd Annual Drug Repositioning Conference will discuss what has changed in the last year and what continues to drive interest in drug repositioning. Case studies will give attendees concrete examples of successfully repositioned drugs and there will be a focus on the best pathway to success for repositioning drugs.
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.
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, please click here: http://www.zogenix.com/downloads/SV0468.0611_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, 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. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER and an Investigational New Drug Application for Relday. The FDA assigned a PDUFA target action date of March 1, 2013 for the Zohydro ER NDA.
For additional information, please visit www.zogenix.com.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.
CONTACT: ZOGENIX INVESTORS: Zack Kubow | The Ruth Group 646.536.7020 | [email protected] ZOGENIX MEDIA: Victoria Aguiar | The Ruth Group 646.536.7013 | [email protected]