SAN DIEGO, Feb. 10, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX) announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.
Study 801 is a randomized, 12-week, double-blind, placebo-controlled trial evaluating ZX002 in opioid-experienced adult subjects with moderate to severe chronic lower back pain. The primary efficacy endpoint is the mean change in average daily pain intensity scores between ZX002 and placebo.
Initial top-line data from Study 801 and an open-label Phase 3 safety study (Study 802) are anticipated to be available during the second half of 2011. As previously announced, Zogenix has completed enrollment of Study 802 to evaluate overall safety of ZX002 in patients for up to one year.
Pending positive Phase 3 clinical results, Zogenix expects to submit an NDA for ZX002 with U.S. Food and Drug Administration (FDA) by early 2012. If approved, ZX002 has the potential to be the first controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. This novel formulation has the potential to address safety concerns outlined by the FDA regarding the use of certain combination prescription pain products that contain acetaminophen, which can cause liver toxicity at high doses over time. In January 2011, the FDA announced that manufacturers of certain prescription pain products containing acetaminophen will be required to reformulate or discontinue making these products within three years.
Stephen J. Farr, Ph.D., President and Chief Operating Officer said, "After completing enrollment in both Phase 3 studies, ZX002 remains positioned as the first potential single-entity, controlled-release hydrocodone product. Since it does not contain acetaminophen and allows for convenient twice daily dosing, ZX002 may fulfill a beneficial treatment option for both patients using immediate-release hydrocodone combination products on a chronic basis and an alternative for patients already using extended-release opioids for the management of their moderate to severe pain. We look forward to obtaining top-line safety data from Study 802 and efficacy and safety data from Study 801 during the second half of this year to support a potential NDA submission by early-2012."
Nathaniel P. Katz, M.D., Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine, said, "In light of the recent FDA decision and the public concern over the risks of liver toxicity associated with high doses of acetaminophen, having a new medication option of hydrocodone without the combination of acetaminophen will be an important addition to the management and care of 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 United States, generating $3.1 billion in U.S. sales during the 12 months ended June 2010 (Wolters Kluwer Pharma Solutions, Source(R): PHAST Retail). All of these hydrocodone products contain an analgesic combination ingredient, primarily acetaminophen. When used in high dosages over time, acetaminophen can cause liver toxicity.
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 an extended period of time. ZX002 uses Elan Pharma International Limited's proprietary Spheroidal Oral Drug Absorption System, or SODAS® Technology. The SODAS technology serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations.
If approved, ZX002 may represent the first available controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. The Phase 3 clinical development program for ZX002 was initiated in March 2010 and initial top-line data are anticipated in the second half of 2011. Pending positive Phase 3 clinical results, Zogenix expects to submit a new drug application (NDA) for ZX002 with U.S. Food and Drug Administration (FDA) by early 2012.
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, 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.
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SODAS is a registered trademark of Elan Pharma International Ltd.
SUMAVEL is a registered trademark and DosePro is a 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 timing of results from Study 801 and Study 802, the timing of an NDA filing, the potential to address FDA safety concerns concerning combination prescription pain products that contain acetaminophen, and the potential to be the first controlled-release version of hydrocodone and the first hydrocodone product that is not combined with another analgesic. 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 the business of Zogenix, including, without limitation: the progress and timing of the company's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the potential for ZX002 to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to ZX002 to delay or prevent regulatory approval or commercialization, or result in product liability claims; uncertainties in the regulatory review and approval process, including potential FDA requirements for additional studies prior to NDA submission or approval; the risk that competitors, who may have significantly greater financial and administrative resources, will be able to advance similar products through clinical development and regulatory approval more rapidly than Zogenix; the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates; and other risks described in the company's 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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