Zogenix to Hold Conference Call to Discuss Pivotal Phase 3 Results for Zohydro for Treatment of Chronic Pain
SAN DIEGO, Aug 16, 2011 (GlobeNewswire via COMTEX) --
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it will host a conference call at 8:30 a.m. ET on Wednesday, August 17, 2011, to discuss the top-line results from its pivotal Phase 3 efficacy study (801) of Zohydro(TM) (hydrocodone bitartrate) extended-release capsules. Zohydro is being evaluated for the treatment of moderate to severe chronic pain in patients requiring around the clock opioid therapy for an extended period of time. If approved, Zohydro would be the first extended-release hydrocodone treatment and the first hydrocodone product without acetaminophen. Acetaminophen is associated with increased risk of liver toxicity when used in high doses over time. Zogenix will announce the top-line results from the Phase 3 efficacy study in a press release distributed prior to the conference call.
To participate, please dial 866-788-0544 (U.S.) or 857-350-1682 (International); participant passcode: 60568209. To access the live webcast, please visit the Zogenix Investor Relations website at http://ir.zogenix.com.
A replay of the conference call will be available beginning August 17, 2011 at 11:30 AM ET and ending on September 17, 2011 by dialing 888-286-8010 (U.S.) or 617-801-6888 (International); passcode: 35366758. A replay of the webcast will also be available on the Zogenix Investor Relations website for one month, through September 17, 2011.
About the Phase 3 Efficacy Study (801)
The multi-center randomized, double-blind, placebo-controlled study enrolled opioid-experienced patients, aged 18-75, who had an established clinical diagnosis of moderate to severe chronic lower back pain and inadequate pain relief from their existing therapy. The trial consisted of an open-label conversion and titration phase of Zohydro, followed by a 12-week placebo-controlled treatment phase comparing Zohydro 20-100 mg every 12 hours to placebo. More than 300 patients were randomized into the double-blind treatment phase.
The primary objective of this study was to evaluate the relative efficacy of Zohydro as measured by the change from baseline to the end of treatment in pain intensity. The protocol specified primary endpoint was the mean change from baseline to the end of 12 weeks of treatment in the average 24-hour pain intensity ratings based on the 0-10 Numerical Rating Scale (NRS) from daily electronic diaries comparing Zohydro and placebo.
Zohydro is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. When used in high dosages over time, acetaminophen is associated with increased risk of liver toxicity. If approved, Zohydro could be the first single-entity hydrocodone therapy available. Zohydro uses Elan's patented Spheriodal Oral Drug Absorption System (SODAS(R)) drug delivery technology which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate release combination products. Capsule strengths utilized in the Phase 3 study included 10, 20, 30, 40 and 50 mg capsules.
About Chronic Pain
The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. Chronic pain can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the U.S., generating $3.2 billion in sales during the 12 months ended December 2010 (Wolters Kluwer Pharma Solutions, Source Pharmaceutical Audit Suite Retail, January 2010 -- December 2010). All of these hydrocodone products contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen is a leading cause of liver injury when used in high dosages over time.
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 product candidate, Zohydro(TM) (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second DosePro product candidate, Relday(TM), is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. Zogenix expects to begin clinical studies of Relday in early 2012.
For additional information, please visit www.zogenix.com.
SODAS(R) is a trademark of Elan Drug Technologies.
SUMAVEL(R), DosePro (R), Relday(TM) and Zohydro(TM) are trademarks of Zogenix, Inc.
This news release was distributed by GlobeNewswire, www.globenewswire.com
Zack Kubow | The Ruth Group
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Victoria Aguiar | The Ruth Group